{"id":"penicillin-g-benzathine","_fda":{"id":"4b3694af-9d77-487f-8838-b75aec6636da","set_id":"012d46f1-d0a0-4676-a879-cd320297ab16","openfda":{"unii":["RIT82F58GK"],"route":["INTRAMUSCULAR"],"rxcui":["731564","731566","731567","731568","731570","731571"],"spl_id":["4b3694af-9d77-487f-8838-b75aec6636da"],"brand_name":["BICILLIN L-A"],"spl_set_id":["012d46f1-d0a0-4676-a879-cd320297ab16"],"package_ndc":["60793-700-01","60793-700-10","60793-701-02","60793-701-10","60793-702-04","60793-702-10"],"product_ndc":["60793-700","60793-701","60793-702"],"generic_name":["PENICILLIN G BENZATHINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["PENICILLIN G BENZATHINE"],"manufacturer_name":["Pfizer Laboratories Div Pfizer Inc"],"application_number":["NDA050141"],"is_original_packager":[true]},"version":"34","warnings":["WARNINGS WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. Penicillin G benzathine should only be prescribed for the indications listed in this insert. Anaphylaxis SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH BICILLIN L-A, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, BICILLIN L-A SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients taking penicillin G (the active moiety in Bicillin L-A). When SCAR is suspected, Bicillin L-A should be discontinued immediately and an alternative treatment should be considered. Clostridioides difficile associated diarrhea Clostridioides difficile associated-diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Bicillin L-A, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Method of Administration Do not inject into or near an artery or nerve. See administration instructions below. Injection into or near a nerve may result in permanent neurological damage. Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or injection immediately adjacent to arteries, of Bicillin L-A and other penicillin preparations has resulted in severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of digits and more proximal portions of extremities, and necrosis and sloughing at and surrounding the injection site consistent with the diagnosis of Nicolau syndrome. Such severe effects have been reported following injections into the buttock, thigh, and deltoid areas. Other serious complications of suspected intravascular administration which have been reported include immediate pallor, mottling, or cyanosis of the extremity both distal and proximal to the injection site, followed by bleb formation; severe edema requiring anterior and/or posterior compartment fasciotomy in the lower extremity. The above-described severe effects and complications have most often occurred in infants and small children. Prompt consultation with an appropriate specialist is indicated if any evidence of compromise of the blood supply occurs at, proximal to, or distal to the site of injection. 1–9 (See PRECAUTIONS , and DOSAGE AND ADMINISTRATION sections.) FOR DEEP INTRAMUSCULAR INJECTION ONLY. There have been reports of inadvertent intravenous administration of penicillin G benzathine which has been associated with cardiorespiratory arrest and death. Therefore, do not inject intravenously or admix with other intravenous solutions. (See DOSAGE AND ADMINISTRATION section.) Administer by DEEP INTRAMUSCULAR INJECTION ONLY in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site. Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh. Because of these adverse effects and the vascularity of this region, administration in the anterolateral thigh is not recommended."],"pregnancy":["Pregnancy Teratogenic effects Pregnancy Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."],"overdosage":["OVERDOSAGE Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures."],"references":["REFERENCES 1. SHAW, E.: Transverse myelitis from injection of penicillin. Am. J. Dis. Child., 111: 548, 1966. 2. KNOWLES, J.: Accidental intra-arterial injection of penicillin. Am. J. Dis. Child., 111: 552, 1966. 3. DARBY, C. et al : Ischemia following an intragluteal injection of benzathine-procaine penicillin G mixture in a one-year-old boy. Clin. Pediatrics, 12: 485, 1973. 4. BROWN, L. & NELSON, A.: Postinfectious intravascular thrombosis with gangrene. Arch. Surg., 94: 652, 1967. 5. BORENSTINE, J.: Transverse myelitis and penicillin (Correspondence). Am. J. Dis. Child., 112: 166, 1966. 6. ATKINSON, J.: Transverse myelopathy secondary to penicillin injection. J. Pediatrics, 75: 867, 1969. 7. TALBERT, J. et al : Gangrene of the foot following intramuscular injection in the lateral thigh: A case report with recommendations for prevention. J. Pediatrics, 70: 110, 1967. 8. FISHER, T.: Medicolegal affairs. Canad. Med. Assoc. J., 112: 395, 1975. 9. SCHANZER, H. et al : Accidental intra-arterial injection of penicillin G. JAMA, 242: 1289, 1979."],"description":["Description Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2 S , 5 R , 6 R )-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' - dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows: Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.65% sodium citrate, 0.59% povidone, 0.54% carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben, and 0.013% propylparaben. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000 (actual volume of 1.17 mL contains 620,100), 1,200,000 (actual volume of 2.34 mL contains 1,240,200), and 2,400,000 (actual volume of 4.67 mL contains 2,475,100) units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS , WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION sections prior to use. Chemical Structure"],"precautions":["PRECAUTIONS General Prescribing Bicillin L-A in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of a development of drug-resistant bacteria. Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injection may produce neurovascular damage. (See WARNINGS , and DOSAGE AND ADMINISTRATION sections.) Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be counseled that antibacterial drugs including Bicillin L-A should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bicillin L-A is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Bicillin L-A or other antibacterial drugs in the future. Laboratory Tests In streptococcal infections, therapy must be sufficient to eliminate the organism; otherwise, the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated. Drug Interactions Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Pregnancy Teratogenic effects Pregnancy Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Soluble penicillin G (the hydrolysate of penicillin G benzathine) is excreted in breast milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been conducted with this drug. Pediatric Use (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.) Geriatric Use Clinical studies of penicillin G benzathine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See CLINICAL PHARMACOLOGY .) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"how_supplied":["HOW SUPPLIED Bicillin L-A (penicillin G benzathine injectable suspension) is supplied in packages of 10 disposable syringes as follows: 1 mL size, containing 600,000 units per syringe, (21 gauge, thin-wall 1-inch needle for pediatric use), with 0.11 mEq of sodium per 600,000 units of penicillin G (2.59 mg of sodium per 600,000 units of penicillin G), NDC 60793-700-10. 2 mL size, containing 1,200,000 units per syringe, (21 gauge, thin-wall 1-1/2-inch needle), with 0.22 mEq of sodium per 1,200,000 units of penicillin G (5.17 mg of sodium per 1,200,000 units of penicillin G), NDC 60793-701-10. 4 mL size, containing 2,400,000 units per syringe (18 gauge, × 1–1/2-inch needle), with 0.45 mEq of sodium per 2,400,000 units of penicillin G (10.32 mg of sodium per 2,400,000 units of penicillin G), NDC 60793-702-10. Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing."],"microbiology":["Microbiology Mechanism of Action Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall peptidoglycan, rendering the cell wall osmotically unstable. Resistance Penicillin is not active against penicillinase-producing bacteria or against organisms resistant to beta-lactams because of alterations in the penicillin-binding proteins. Resistance to penicillin G has not been reported in Streptococcus pyogenes . Antimicrobial Activity Penicillin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive bacteria Beta-hemolytic streptococci (groups A, B, C, G, H, L and M). Other microorganisms Treponema pallidum Treponema carateum Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC ."],"boxed_warning":["WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.","WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling."],"geriatric_use":["Geriatric Use Clinical studies of penicillin G benzathine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See CLINICAL PHARMACOLOGY .) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"pediatric_use":["Pediatric Use (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.)"],"effective_time":"20240712","nursing_mothers":["Nursing Mothers Soluble penicillin G (the hydrolysate of penicillin G benzathine) is excreted in breast milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman."],"laboratory_tests":["Laboratory Tests In streptococcal infections, therapy must be sufficient to eliminate the organism; otherwise, the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated."],"adverse_reactions":["ADVERSE REACTIONS As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria. As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported. The following adverse reactions have been reported with Bicillin L-A during post-marketing experience: Skin and Appendages: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS). (See WARNINGS .) Immune System Disorders: Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction (Kounis syndrome). The following have been reported with parenteral penicillin G (the active moiety in Bicillin L-A): General: Hypersensitivity reactions including the following: skin eruptions (maculopapular to exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia; other serum sickness-like reactions (including chills, fever, edema, arthralgia, and prostration); and anaphylaxis including shock and death: severe cutaneous adverse reactions (SCAR), such as toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). (See WARNINGS .) Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, penicillin G should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to therapy with penicillin G. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. Gastrointestinal: Pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See WARNINGS section.) Hematologic: Hemolytic anemia, leukopenia, thrombocytopenia. Neurologic: Neuropathy. Urogenital: Nephropathy. The following adverse events have been temporally associated with parenteral administration of penicillin G benzathine (a component of Bicillin L-A): Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus, fatigue, asthenia, and pain; aggravation of existing disorder; headache, Nicolau syndrome. Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary hypertension; pulmonary embolism; vasodilation; vasovagal reaction; cerebrovascular accident; syncope. Gastrointestinal: Nausea, vomiting; blood in stool; intestinal necrosis. Hemic and Lymphatic: Lymphadenopathy. Injection Site: Injection site reactions including pain, inflammation, lump, abscess, necrosis, edema, hemorrhage, cellulitis, hypersensitivity, atrophy, ecchymosis, and skin ulcer. Neurovascular reactions including warmth, vasospasm, pallor, mottling, gangrene, numbness of the extremities, cyanosis of the extremities, and neurovascular damage. Metabolic: Elevated BUN, creatinine, and SGOT. Musculoskeletal: Joint disorder; periostitis; exacerbation of arthritis; myoglobinuria; rhabdomyolysis. Nervous System: Nervousness; tremors; dizziness; somnolence; confusion; anxiety; euphoria; transverse myelitis; seizures; coma. A syndrome manifested by a variety of CNS symptoms such as severe agitation with confusion, visual and auditory hallucinations, and a fear of impending death (Hoigne's syndrome), has been reported after administration of penicillin G procaine and, less commonly, after injection of the combination of penicillin G benzathine and penicillin G procaine. Other symptoms associated with this syndrome, such as psychosis, seizures, dizziness, tinnitus, cyanosis, palpitations, tachycardia, and/or abnormal perception in taste, also may occur. Respiratory: Hypoxia; apnea; dyspnea. Skin: Diaphoresis. Special Senses: Blurred vision; blindness. Urogenital: Neurogenic bladder; hematuria; proteinuria; renal failure; impotence; priapism."],"contraindications":["CONTRAINDICATIONS A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication."],"drug_interactions":["Drug Interactions Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin."],"general_precautions":["General Prescribing Bicillin L-A in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of a development of drug-resistant bacteria. Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injection may produce neurovascular damage. (See WARNINGS , and DOSAGE AND ADMINISTRATION sections.) Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G)."],"mechanism_of_action":["Mechanism of Action Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall peptidoglycan, rendering the cell wall osmotically unstable."],"storage_and_handling":["Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY General Penicillin G benzathine has an extremely low solubility and, thus, the drug is slowly released from intramuscular injection sites. The drug is hydrolyzed to penicillin G. This combination of hydrolysis and slow absorption results in blood serum levels much lower but much more prolonged than other parenteral penicillins. Intramuscular administration of 300,000 units of penicillin G benzathine in adults results in blood levels of 0.03 to 0.05 units per mL, which are maintained for 4 to 5 days. Similar blood levels may persist for 10 days following administration of 600,000 units and for 14 days following administration of 1,200,000 units. Blood concentrations of 0.003 units per mL may still be detectable 4 weeks following administration of 1,200,000 units. Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines. Penicillin G penetrates into all other tissues and the spinal fluid to a lesser degree. With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and young infants and in individuals with impaired kidney function, excretion is considerably delayed. Microbiology Mechanism of Action Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall peptidoglycan, rendering the cell wall osmotically unstable. Resistance Penicillin is not active against penicillinase-producing bacteria or against organisms resistant to beta-lactams because of alterations in the penicillin-binding proteins. Resistance to penicillin G has not been reported in Streptococcus pyogenes . Antimicrobial Activity Penicillin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. Gram-positive bacteria Beta-hemolytic streptococci (groups A, B, C, G, H, L and M). Other microorganisms Treponema pallidum Treponema carateum Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC ."],"indications_and_usage":["INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine: Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections —Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis: Rheumatic fever and/or chorea —Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis."],"information_for_patients":["Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be counseled that antibacterial drugs including Bicillin L-A should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bicillin L-A is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Bicillin L-A or other antibacterial drugs in the future."],"spl_unclassified_section":["For deep IM injection only.","To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.","LAB-0588-20.0 Revised: 09/2023 Logo"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Streptococcal (Group A) Upper Respiratory Infections (for example, pharyngitis) Adults—a single injection of 1,200,000 units; older pediatric patients—a single injection of 900,000 units; infants and pediatric patients under 60 lbs.—300,000 to 600,000 units. Syphilis Primary, secondary, and latent—2,400,000 units (1 dose). Late (tertiary and neurosyphilis)—2,400,000 units at 7-day intervals for three doses. Congenital—under 2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust dosage based on adult dosage schedule. Yaws, Bejel, and Pinta —1,200,000 units (1 injection). Prophylaxis —for rheumatic fever and glomerulonephritis. Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks. METHOD OF ADMINISTRATION BICILLIN L-A IS INTENDED FOR INTRAMUSCULAR INJECTION ONLY. DO NOT INJECT INTO OR NEAR AN ARTERY OR NERVE, OR INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. (SEE WARNINGS SECTION.) Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. Administration in the anterolateral thigh is not recommended due to the adverse effects observed (see WARNINGS section), and vascularity of this region. When doses are repeated, vary the injection site. Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit."],"spl_product_data_elements":["BICILLIN L-A penicillin G benzathine PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POVIDONE, UNSPECIFIED METHYLPARABEN PROPYLPARABEN SODIUM CITRATE, UNSPECIFIED FORM WATER BICILLIN L-A penicillin G benzathine PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POVIDONE, UNSPECIFIED METHYLPARABEN PROPYLPARABEN SODIUM CITRATE, UNSPECIFIED FORM WATER BICILLIN L-A penicillin G benzathine PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POVIDONE, UNSPECIFIED METHYLPARABEN PROPYLPARABEN SODIUM CITRATE, UNSPECIFIED FORM WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label NDC 60793-700-01 BICILLIN ® L-A (penicillin G benzathine injectable suspension) 600,000 units per 1 mL FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES Distributed by Pfizer Inc New York, NY 10017 PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label","PRINCIPAL DISPLAY PANEL - 1 mL Syringe Package NDC 60793-700-10 Contains 10 of NDC 60793-700-01 Ten Syringes (1 mL size) Bicillin ® L-A (penicillin G benzathine injectable suspension) 600,000 units per 1 mL FOR PEDIATRIC USE FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES BEFORE INJECTING, SEE PACKAGE INSERT FOR ADMINISTRATION INSTRUCTIONS. Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 1 mL Syringe Package","PRINCIPAL DISPLAY PANEL - 2 mL Syringe Label NDC 60793-701-02 BICILLIN ® L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES Distributed by Pfizer Inc New York, NY 10017 PRINCIPAL DISPLAY PANEL - 2 mL Syringe Label","PRINCIPAL DISPLAY PANEL - 2 mL Syringe Package NDC 60793-701-10 Contains 10 of NDC 60793-701-02 Ten Syringes (2 mL size) Bicillin ® L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES BEFORE INJECTING, SEE PACKAGE INSERT FOR ADMINISTRATION INSTRUCTIONS. Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 2 mL Syringe Package","PRINCIPAL DISPLAY PANEL - 4 mL Syringe Label NDC 60793-702-04 BICILLIN ® L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES Distributed by Pfizer Inc New York, NY 10017 PRINCIPAL DISPLAY PANEL - 4 mL Syringe Label","PRINCIPAL DISPLAY PANEL - 4 mL Syringe Package NDC 60793-702-10 Contains 10 of NDC 60793-702-04 Ten Syringes (4 mL size) Bicillin ® L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL disposable syringe FOR DEEP INTRAMUSCULAR INJECTION ONLY WARNING: FATAL IF GIVEN BY OTHER ROUTES BEFORE INJECTING, SEE PACKAGE INSERT FOR ADMINISTRATION INSTRUCTIONS. Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 4 mL Syringe Package"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been conducted with this drug."]},"safety":{"boxedWarnings":["WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.\nWARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling."],"safetySignals":[{"date":"","signal":"RECALLED PRODUCT ADMINISTERED","source":"FDA FAERS","actionTaken":"565 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"79 reports"},{"date":"","signal":"INJECTION SITE PAIN","source":"FDA FAERS","actionTaken":"65 reports"},{"date":"","signal":"EMBOLIA CUTIS MEDICAMENTOSA","source":"FDA FAERS","actionTaken":"49 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"47 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"47 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"32 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"30 reports"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"29 reports"}],"commonSideEffects":[{"effect":"Injection site pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Skin eruptions (maculopapular to exfoliative dermatitis)","drugRate":"","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Fever","drugRate":"","severity":"common","organSystem":""},{"effect":"Chills","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Injection site inflammation","drugRate":"","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Asthenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Eosinophilia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nervousness","drugRate":"","severity":"common","organSystem":""},{"effect":"Anxiety","drugRate":"","severity":"common","organSystem":""},{"effect":"Tremors","drugRate":"","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Anaphylaxis including shock and death","drugRate":"","severity":"serious"},{"effect":"Stevens-Johnson syndrome (SJS)","drugRate":"","severity":"serious"},{"effect":"Toxic epidermal necrolysis (TEN)","drugRate":"","severity":"serious"},{"effect":"Drug reaction with eosinophilia and systemic symptoms (DRESS)","drugRate":"","severity":"serious"},{"effect":"Acute myocardial ischemia with or without myocardial infarction (Kounis syndrome)","drugRate":"","severity":"serious"},{"effect":"Pseudomembranous colitis","drugRate":"","severity":"serious"},{"effect":"Cardiac arrest","drugRate":"","severity":"serious"},{"effect":"Pulmonary embolism","drugRate":"","severity":"serious"},{"effect":"Transverse myelitis","drugRate":"","severity":"serious"},{"effect":"Rhabdomyolysis","drugRate":"","severity":"serious"}]},"_chembl":{"chemblId":"CHEMBL3989515","moleculeType":"Small molecule","molecularWeight":"981.20"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PENICILLIN G BENZATHINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:41:49.712483+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:41:56.246099+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T02:41:48.341621+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PENICILLIN G BENZATHINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:41:57.043938+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:41:39.183095+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling.\nWARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS ","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:41:39.183160+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T02:41:59.211285+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"Mechanism of Action Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall peptidoglycan, rendering the cell wall osmotically unstable.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:42:09.067427+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial penicillin-binding protein inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:41:58.137471+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989515/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:41:58.036693+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA050141","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:41:39.183173+00:00"}},"_dailymed":{"setId":"012d46f1-d0a0-4676-a879-cd320297ab16","title":"BICILLIN L-A (PENICILLIN G BENZATHINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]"},"mechanism":{"target":"cell-wall peptidoglycan","explanation":"Penicillin G works by stopping the bacteria from building their cell walls properly. This makes the cell walls weak and unable to protect the bacteria, leading to their death.","oneSentence":"Penicillin G kills bacteria by inhibiting cell-wall peptidoglycan synthesis, making the cell wall unstable.","technicalDetail":"Penicillin G exerts its bactericidal action by inhibiting the biosynthesis of cell-wall peptidoglycan, which is essential for maintaining the structural integrity and osmotic stability of the bacterial cell wall."},"_scrapedAt":"2026-03-27T23:33:24.826Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:42:12.832365+00:00","fieldsConflicting":0,"overallConfidence":0.95},"trialDetails":[{"nctId":"NCT07498153","phase":"NA","title":"Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2025-09-30","conditions":"Syphilis, HIV Infections","enrollment":149},{"nctId":"NCT07207876","phase":"","title":"Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy","status":"RECRUITING","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","startDate":"2026-02-16","conditions":"Pregnancy","enrollment":110},{"nctId":"NCT07492134","phase":"PHASE2","title":"APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)","status":"NOT_YET_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2026-04-01","conditions":"Acute Uncomplicated Diverticulitis","enrollment":100},{"nctId":"NCT06977841","phase":"NA","title":"Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial","status":"COMPLETED","sponsor":"Zhongshan Hospital (Xiamen), Fudan University","startDate":"2025-06-10","conditions":"Helicobacter Pylori Eradication, Adverse Reaction","enrollment":640},{"nctId":"NCT05761080","phase":"PHASE4","title":"Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics","status":"RECRUITING","sponsor":"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","startDate":"2021-04-22","conditions":"Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess","enrollment":772},{"nctId":"NCT04948463","phase":"PHASE4","title":"Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia","status":"COMPLETED","sponsor":"Murdoch Childrens Research Institute","startDate":"2021-11-15","conditions":"Febrile Neutropenia","enrollment":55},{"nctId":"NCT07484633","phase":"PHASE4","title":"A Randomised Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients.","status":"NOT_YET_RECRUITING","sponsor":"Semmelweis University","startDate":"2026-04","conditions":"Infection, Sepsis, NICU","enrollment":110},{"nctId":"NCT07485010","phase":"PHASE2","title":"Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","status":"NOT_YET_RECRUITING","sponsor":"The University of Queensland","startDate":"2027-04","conditions":"Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Infections","enrollment":300},{"nctId":"NCT06406114","phase":"PHASE2","title":"Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-05-05","conditions":"Drug Allergy, Cephalosporin Allergy, Drug Hypersensitivity","enrollment":300},{"nctId":"NCT07481539","phase":"PHASE2","title":"Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment","status":"RECRUITING","sponsor":"Azienda Sanitaria Universitaria Friuli Centrale","startDate":"2026-03-24","conditions":"Bacteria Infection, Piperacillin, Tazobactam Drug Combination","enrollment":240},{"nctId":"NCT07483736","phase":"PHASE3","title":"Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients.","status":"NOT_YET_RECRUITING","sponsor":"Versailles Hospital","startDate":"2026-03","conditions":"C15.378","enrollment":1526},{"nctId":"NCT05693545","phase":"PHASE2","title":"GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2023-09-01","conditions":"Rheumatic Heart Disease","enrollment":1004},{"nctId":"NCT06154174","phase":"NA","title":"Choline to Improve Malnutrition and Enhance Cognition","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2023-12-05","conditions":"Severe Acute Malnutrition, Cognitive Impairment, Wasting","enrollment":1500},{"nctId":"NCT06712641","phase":"PHASE4","title":"Aminoglycosides in Early Sepsis","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Akershus","startDate":"2026-04","conditions":"Sepsis","enrollment":1900},{"nctId":"NCT05548426","phase":"PHASE2","title":"Linezolid for Syphilis Pilot Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Southern California","startDate":"2023-09-28","conditions":"Syphilis","enrollment":24},{"nctId":"NCT05834036","phase":"PHASE4","title":"Effect of Antibiotics on Enteric Neurons and Glia","status":"COMPLETED","sponsor":"Rockefeller University","startDate":"2023-06-23","conditions":"Antibiotic Enterocolitis","enrollment":10},{"nctId":"NCT00713947","phase":"PHASE4","title":"Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control","status":"WITHDRAWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2008-04","conditions":"Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis","enrollment":""},{"nctId":"NCT07457385","phase":"PHASE4","title":"Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-11-01","conditions":"Syphilis, Congenital","enrollment":374},{"nctId":"NCT07451171","phase":"PHASE2","title":"Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children","status":"NOT_YET_RECRUITING","sponsor":"University of Virginia","startDate":"2026-04","conditions":"Small Intestine Bacterial Overgrowth","enrollment":60},{"nctId":"NCT03078010","phase":"PHASE2","title":"Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2017-02-10","conditions":"Intestinal Microbiome, Febrile Neutropenia","enrollment":347},{"nctId":"NCT06076304","phase":"PHASE4","title":"Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis","status":"RECRUITING","sponsor":"Daniel Merenstein","startDate":"2023-11-21","conditions":"Sinus Infection, Acute Sinusitis","enrollment":3720},{"nctId":"NCT06494072","phase":"PHASE4","title":"Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP","status":"RECRUITING","sponsor":"Medical College of Wisconsin","startDate":"2024-08-22","conditions":"Community Acquired Pneumonia in Children","enrollment":236},{"nctId":"NCT04514653","phase":"PHASE2","title":"RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"AbbVie","startDate":"2020-08-25","conditions":"Neovascular Age-Related Macular Degeneration (nAMD)","enrollment":146},{"nctId":"NCT05980871","phase":"PHASE4","title":"Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline","status":"TERMINATED","sponsor":"National Taiwan University Hospital","startDate":"2023-03-10","conditions":"Early Syphilis","enrollment":109},{"nctId":"NCT05398679","phase":"PHASE4","title":"Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis","status":"RECRUITING","sponsor":"Fundacion Clinic per a la Recerca Biomédica","startDate":"2022-08-17","conditions":"Endocarditis Infective","enrollment":360},{"nctId":"NCT05894954","phase":"PHASE3","title":"Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment","status":"COMPLETED","sponsor":"Alzheimer's Prevention and Reversal Project, Inc.","startDate":"2023-07-31","conditions":"Mild Cognitive Impairment, Dementia, Mild","enrollment":73},{"nctId":"NCT06340724","phase":"PHASE3","title":"Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication","status":"COMPLETED","sponsor":"Nanjing First Hospital, Nanjing Medical University","startDate":"2024-02-15","conditions":"Helicobacter Pylori Infection","enrollment":104},{"nctId":"NCT06156085","phase":"PHASE4","title":"Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy","status":"COMPLETED","sponsor":"Fu Jen Catholic University Hospital","startDate":"2023-11-14","conditions":"Helicobacter Pylori Infection","enrollment":337},{"nctId":"NCT06954129","phase":"PHASE4","title":"A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2026-01-28","conditions":"Acute Kidney Injury","enrollment":750},{"nctId":"NCT07293910","phase":"PHASE2","title":"Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","status":"RECRUITING","sponsor":"Tanta University","startDate":"2026-02-15","conditions":"HELICOBACTER PYLORI INFECTIONS, Helicobacter Infection, Helicobacter Pylori Gastrointestinal Tract Infection","enrollment":66},{"nctId":"NCT02701595","phase":"PHASE3","title":"Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2016-02-29","conditions":"Infective Endocarditis","enrollment":324},{"nctId":"NCT03511118","phase":"","title":"Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants","status":"RECRUITING","sponsor":"Duke University","startDate":"2018-10-04","conditions":"Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI","enrollment":1600},{"nctId":"NCT06123169","phase":"PHASE3","title":"Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2026-04","conditions":"Pancreaticoduodenectomy, Antibiotherapy","enrollment":326},{"nctId":"NCT05100654","phase":"EARLY_PHASE1","title":"Collaborative Urological Prosthetics Investigation Directive Research Group","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Chicago","startDate":"2022-04-22","conditions":"Erectile Dysfunction, Penile Prosthesis Infection","enrollment":800},{"nctId":"NCT04986254","phase":"","title":"PNEUmonia DOSing in Critically Ill Patients (PNEUDOS)","status":"COMPLETED","sponsor":"The University of Queensland","startDate":"2019-10-17","conditions":"Pneumonia","enrollment":179},{"nctId":"NCT06396078","phase":"PHASE4","title":"Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)","status":"RECRUITING","sponsor":"Ohio State University","startDate":"2024-07-18","conditions":"Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth","enrollment":56},{"nctId":"NCT06229288","phase":"PHASE3","title":"Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward","status":"RECRUITING","sponsor":"Nantes University Hospital","startDate":"2024-04-25","conditions":"Community-acquired Pneumonia","enrollment":326},{"nctId":"NCT06510010","phase":"PHASE2","title":"Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer","status":"RECRUITING","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","startDate":"2024-12-31","conditions":"Chemotherapy Effect","enrollment":198},{"nctId":"NCT07358130","phase":"NA","title":"Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy","status":"RECRUITING","sponsor":"Kaohsiung Medical University","startDate":"2025-10-21","conditions":"Helicobacter Pylori Infection","enrollment":552},{"nctId":"NCT06426836","phase":"NA","title":"Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)","status":"RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2016-08-19","conditions":"Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam","enrollment":300},{"nctId":"NCT05647278","phase":"PHASE4","title":"Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)","status":"COMPLETED","sponsor":"Zhang Xiaofeng,MD","startDate":"2023-11-01","conditions":"Helicobacter Pylori Infection","enrollment":370},{"nctId":"NCT06349486","phase":"NA","title":"Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication","status":"RECRUITING","sponsor":"Kaohsiung Medical University","startDate":"2023-11-28","conditions":"Helicobacter Pylori Eradication","enrollment":390},{"nctId":"NCT02783859","phase":"PHASE4","title":"Hospitalised Pneumonia With Extended Treatment (HOPE) Study","status":"COMPLETED","sponsor":"Menzies School of Health Research","startDate":"2016-06","conditions":"Pneumonia","enrollment":314},{"nctId":"NCT04549311","phase":"PHASE3","title":"Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial","status":"COMPLETED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2021-11-18","conditions":"Perianal Abscess, Perianal Fistula","enrollment":15},{"nctId":"NCT07015736","phase":"PHASE4","title":"Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eskisehir Osmangazi University","startDate":"2025-08-01","conditions":"Antibiotic Associated Diarrhea, Acute Otitis Media, ACUTE SINUSITIS","enrollment":100},{"nctId":"NCT07294846","phase":"PHASE1","title":"Drug Interaction Study on Linaprazan Glurate Capsules","status":"COMPLETED","sponsor":"Jiangsu Sinorda Biomedicine Co., Ltd","startDate":"2025-09-08","conditions":"Healthy Volunteers, Patients","enrollment":56},{"nctId":"NCT05079620","phase":"PHASE4","title":"Early Antibiotics After Aspiration in ICU Patients","status":"TERMINATED","sponsor":"UConn Health","startDate":"2021-11-30","conditions":"Aspiration, Aspiration Pneumonia","enrollment":5},{"nctId":"NCT07296302","phase":"NA","title":"Antibiotic Prophylaxis Versus Placebo in Alveolar Bone Grafting: A Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Agnaldo Rocha de Souza Junior","startDate":"2026-02","conditions":"Alveolar Ridge Augmentation, Bone Grafting, Antibiotic Prophylaxis","enrollment":150},{"nctId":"NCT07304882","phase":"PHASE3","title":"A Comparison of Recovery After Impacted Wisdom Tooth Removal","status":"COMPLETED","sponsor":"University of Science and Technology, Yemen","startDate":"2023-11-30","conditions":"Impacted Mandibular Third Molar Extraction, Post Operative Complications","enrollment":24},{"nctId":"NCT07275827","phase":"PHASE3","title":"Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection","status":"NOT_YET_RECRUITING","sponsor":"Tanta University","startDate":"2026-02-01","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":88},{"nctId":"NCT02281929","phase":"PHASE3","title":"Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone","status":"COMPLETED","sponsor":"University Hospital, Lille","startDate":"2015-06-13","conditions":"Alcoholic Hepatitis, Alcoholic Liver Disease","enrollment":297},{"nctId":"NCT07183462","phase":"PHASE4","title":"Azithromycin and Ampicillin for Late PPROM","status":"RECRUITING","sponsor":"Sheba Medical Center","startDate":"2025-09-10","conditions":"Pregnancy Complications, Infectious, Premature Birth, Neonatal Diseases and Abnormalities","enrollment":311},{"nctId":"NCT07146048","phase":"PHASE3","title":"A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop","status":"NOT_YET_RECRUITING","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2026-02","conditions":"Rheumatic Heart Disease","enrollment":922},{"nctId":"NCT06869850","phase":"NA","title":"Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2025-09-22","conditions":"Severe Acute Malnutrition, Cognitive Impairment, Kwashiorkor","enrollment":1600},{"nctId":"NCT05309928","phase":"PHASE1","title":"Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2023-08-29","conditions":"Pregnancy Related","enrollment":13},{"nctId":"NCT05926804","phase":"NA","title":"A \"Screen and Treat\" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile","status":"RECRUITING","sponsor":"Miguel O'Ryan Gallardo","startDate":"2022-08-02","conditions":"Helicobacter Pylori Infection","enrollment":500},{"nctId":"NCT07275580","phase":"PHASE4","title":"Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","status":"NOT_YET_RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2026-01-10","conditions":"Autoimmune Rheumatic Diseases, Tooth Extraction, Infection Prevention","enrollment":352},{"nctId":"NCT04350502","phase":"NA","title":"Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2019-07-18","conditions":"Pleural Infection, Empyema, Community-acquired Pneumonia","enrollment":11},{"nctId":"NCT05206500","phase":"PHASE4","title":"NextGen - Clinical Implication of Next Generation Sequencing","status":"RECRUITING","sponsor":"Wake Forest University Health Sciences","startDate":"2022-05-17","conditions":"Urinary Tract Infections","enrollment":100},{"nctId":"NCT06751121","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2024-02-06","conditions":"Helicobacter Pylori Infection, Helicobacter Pylori Infected Patients, Helicobacter Pylori Infected Subjects","enrollment":461},{"nctId":"NCT06734260","phase":"PHASE3","title":"Optimization of Keverprazan-amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection","status":"RECRUITING","sponsor":"Eighth Affiliated Hospital, Sun Yat-sen University","startDate":"2024-09-10","conditions":"Helicobacter Pylori Eradication Rate","enrollment":477},{"nctId":"NCT04876131","phase":"PHASE4","title":"Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children","status":"RECRUITING","sponsor":"Murdoch Childrens Research Institute","startDate":"2022-05-30","conditions":"Complicated Urinary Tract Infection, Infection, Pediatric Infectious Disease","enrollment":452},{"nctId":"NCT07260006","phase":"NA","title":"Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease","status":"RECRUITING","sponsor":"Can Tho University of Medicine and Pharmacy","startDate":"2024-10-01","conditions":"Helicobacter Pylori Infection, Peptic Ulcer","enrollment":80},{"nctId":"NCT06823154","phase":"PHASE1","title":"The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department","status":"ENROLLING_BY_INVITATION","sponsor":"The Hospital for Sick Children","startDate":"2023-11-27","conditions":"Allergy Amoxicillin, Beta-lactam Allergy Labels","enrollment":500},{"nctId":"NCT06126731","phase":"PHASE1, PHASE2","title":"Combination Study of Antibiotics With Enzalutamide (PROMIZE)","status":"RECRUITING","sponsor":"Institute of Cancer Research, United Kingdom","startDate":"2023-11-02","conditions":"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","enrollment":39},{"nctId":"NCT07242456","phase":"PHASE2, PHASE3","title":"Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication","status":"RECRUITING","sponsor":"First People's Hospital of Hangzhou","startDate":"2025-02-17","conditions":"Helicobacter Pylori Infection","enrollment":240},{"nctId":"NCT07242443","phase":"PHASE4","title":"Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）","status":"NOT_YET_RECRUITING","sponsor":"First People's Hospital of Hangzhou","startDate":"2025-11-20","conditions":"HELICOBACTER PYLORI INFECTIONS","enrollment":240},{"nctId":"NCT04838717","phase":"PHASE3","title":"Clinical Trial of Doxycycline VS BPG for Early Syphilis (SY-DOXY)","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-12-06","conditions":"Syphilis","enrollment":200},{"nctId":"NCT02473263","phase":"PHASE3","title":"Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-05-09","conditions":"Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit","enrollment":398},{"nctId":"NCT01543334","phase":"","title":"Antibiotic Concentrations Among Critically Ill Patients","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2012-03","conditions":"Administration of Antibiotics in Intensive Care Units","enrollment":98},{"nctId":"NCT06069141","phase":"NA","title":"Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2024-01-01","conditions":"Early Syphilis, Latent, Serological Relapse After Treatment","enrollment":688},{"nctId":"NCT07189208","phase":"PHASE2","title":"Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil","status":"RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2025-11-01","conditions":"Congenital Syphilis","enrollment":500},{"nctId":"NCT07233733","phase":"NA","title":"A Clinical Study of Connective Tissue Graft and Enamel Matrix Derivative in the Treatment of Intrabony Periodontal Defects","status":"COMPLETED","sponsor":"Phạm Đình Thiên Khải","startDate":"2024-06-01","conditions":"Periodontal Diseases, Regeneration","enrollment":17},{"nctId":"NCT03269994","phase":"PHASE3","title":"Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2017-11-21","conditions":"Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases","enrollment":967},{"nctId":"NCT05137119","phase":"PHASE4","title":"Staphylococcus Aureus Network Adaptive Platform Trial","status":"RECRUITING","sponsor":"University of Melbourne","startDate":"2022-02-16","conditions":"Staphylococcus Aureus Bacteremia","enrollment":8000},{"nctId":"NCT05846399","phase":"PHASE4","title":"CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE)","status":"RECRUITING","sponsor":"University of Missouri-Columbia","startDate":"2023-09-07","conditions":"Cat Bite, Hand Injuries, Arm Injury","enrollment":72},{"nctId":"NCT06010719","phase":"PHASE4","title":"Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2024-10-23","conditions":"Malnutrition, Child, Severe Acute Malnutrition","enrollment":3000},{"nctId":"NCT07202091","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-05-06","conditions":"Myeloma, Leukemia, Non Hodgkin's Lymphoma","enrollment":900},{"nctId":"NCT07202052","phase":"PHASE2, PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)","status":"RECRUITING","sponsor":"Monash University","startDate":"2025-05-06","conditions":"Myeloma, Non-Hodgkin's Lymphoma, Leukemia","enrollment":900},{"nctId":"NCT07096310","phase":"PHASE1, PHASE2","title":"Comparison Between Carbapenems and Noncarbapenem Beta-lactam Antibiotics in Septic Burn Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ain Shams University","startDate":"2024-01-01","conditions":"Sepsis","enrollment":400},{"nctId":"NCT06368102","phase":"PHASE4","title":"Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery","status":"COMPLETED","sponsor":"Uji Takeda Hospital","startDate":"2024-05-02","conditions":"Surgical Site Infection","enrollment":70},{"nctId":"NCT03997266","phase":"PHASE4","title":"NICU Antibiotics and Outcomes Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"Michael Morowitz","startDate":"2020-08-05","conditions":"Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis","enrollment":802},{"nctId":"NCT05332444","phase":"PHASE4","title":"Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2022-04-11","conditions":"Helicobacter Pylori Infection","enrollment":450},{"nctId":"NCT01015417","phase":"PHASE3","title":"Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2010-05","conditions":"Acute Lithiasic Cholecystitis Grade I or II, Symptoms Lasting for Less Than 5 Days, Required Cholecystectomy","enrollment":414},{"nctId":"NCT04728516","phase":"PHASE4","title":"The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients","status":"RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2023-04-12","conditions":"Acute Coronary Syndrome, Helicobacter Pylori Infection","enrollment":2600},{"nctId":"NCT05874544","phase":"PHASE4","title":"Rescue Therapy for Helicobacter Pylori Infection","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2023-05-16","conditions":"Helicobacter Pylori Infection","enrollment":360},{"nctId":"NCT02707042","phase":"PHASE1","title":"Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2017-03-22","conditions":"Normal Physiology, Healthy","enrollment":108},{"nctId":"NCT07148622","phase":"NA","title":"Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes","status":"COMPLETED","sponsor":"Yuzuncu Yil University","startDate":"2024-10-01","conditions":"Preterm Premature Rupture of Membranes (PPROM), Prophylaxis, Perinatal Outcomes","enrollment":40},{"nctId":"NCT06451913","phase":"PHASE4","title":"Effect of Saccharomyces Boulardii CNCM I-745 on Gut Microbiota in Patients Undergoing Antibiotic Therapy (in the Context of Erythema Migrans (Early Skin Form of Lyme Borreliosis))","status":"RECRUITING","sponsor":"Biocodex","startDate":"2025-07-16","conditions":"Erythema Migrans of Lyme Disease","enrollment":120},{"nctId":"NCT05977868","phase":"PHASE4","title":"Comparing Oral Versus Parenteral Antimicrobial Therapy","status":"TERMINATED","sponsor":"West Virginia University","startDate":"2023-08-04","conditions":"Endovascular Infection, Bone and Joint Infection, Skin and Soft Tissue Infection","enrollment":94},{"nctId":"NCT05464615","phase":"EARLY_PHASE1","title":"Geisinger Antibiotic Allergy Pilot Program: Assess and Address","status":"RECRUITING","sponsor":"Geisinger Clinic","startDate":"2024-03-04","conditions":"Penicillin Allergy","enrollment":100},{"nctId":"NCT03273296","phase":"PHASE4","title":"Effect of Antibiotics on Gut Microbiome and Plasma Metabolome","status":"COMPLETED","sponsor":"Finnish Institute for Health and Welfare","startDate":"2017-10-15","conditions":"Microbial Colonization","enrollment":39},{"nctId":"NCT05857163","phase":"PHASE3","title":"Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection","status":"COMPLETED","sponsor":"TenNor Therapeutics (Suzhou) Limited","startDate":"2023-05-18","conditions":"H.Pylori Infection","enrollment":700},{"nctId":"NCT07122024","phase":"PHASE4","title":"Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2024-02-19","conditions":"Helicobacter Pylori","enrollment":414},{"nctId":"NCT07068607","phase":"PHASE4","title":"Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial","status":"RECRUITING","sponsor":"Yongquan Shi","startDate":"2025-04-01","conditions":"Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer","enrollment":400},{"nctId":"NCT07115173","phase":"PHASE4","title":"Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication","status":"NOT_YET_RECRUITING","sponsor":"Samsung Medical Center","startDate":"2025-12-01","conditions":"Helicobacter Infection","enrollment":103},{"nctId":"NCT06131021","phase":"PHASE3","title":"Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice","status":"RECRUITING","sponsor":"Rutgers, The State University of New Jersey","startDate":"2024-04-25","conditions":"Periodontitis, Periodontal Diseases, Periodontal Pocket","enrollment":150},{"nctId":"NCT07107477","phase":"PHASE3","title":"TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden","status":"RECRUITING","sponsor":"The Central and Eastern European Gynecologic Oncology Group","startDate":"2025-05-01","conditions":"Preterm Premature Rupture of Membranes (PPROM)","enrollment":138},{"nctId":"NCT05469984","phase":"NA","title":"Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor","status":"RECRUITING","sponsor":"Western Galilee Hospital-Nahariya","startDate":"2022-11-25","conditions":"Preterm Labor With Preterm Delivery, Premature Rupture of Membranes Prolonged","enrollment":600},{"nctId":"NCT06771492","phase":"PHASE3","title":"Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial","status":"RECRUITING","sponsor":"Bart Koes","startDate":"2025-04-02","conditions":"MSK Conditions, Chronic Low Back Pain (CLBP), Modic Changes","enrollment":204}],"_emaApprovals":[],"_faersSignals":[{"count":112,"reaction":"DRUG HYPERSENSITIVITY"},{"count":33,"reaction":"EMBOLIA CUTIS MEDICAMENTOSA"},{"count":29,"reaction":"HYPERSENSITIVITY"},{"count":27,"reaction":"DRUG INEFFECTIVE"},{"count":26,"reaction":"ACUTE KIDNEY INJURY"},{"count":22,"reaction":"RASH"},{"count":19,"reaction":"FOETAL EXPOSURE DURING PREGNANCY"},{"count":18,"reaction":"JARISCH-HERXHEIMER REACTION"},{"count":18,"reaction":"PREMATURE BABY"},{"count":17,"reaction":"URTICARIA"}],"administration":{"route":"Intramuscular"},"crossReferences":{"chemblId":"CHEMBL3989515"},"_approvalHistory":[],"publicationCount":238,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"PENICILLIN G BENZATHINE","genericName":"PENICILLIN G BENZATHINE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1952","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1965-05-07T00:00:00.000Z","mah":"KING PHARMS LLC","brand_name_local":null,"application_number":"NDA050138"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1988-05-03T00:00:00.000Z","mah":"KING PHARMS LLC","brand_name_local":null,"application_number":"NDA050141"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:42:12.832365+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}