{"id":"clavulanic-acid","rwe":[{"pmid":"41898147","year":"2026","title":"Comparative Evaluation of Amoxicillin-Clavulanate and Ertapenem in an Exploratory Rat Model of ESBL E. coli Peritonitis.","finding":"","journal":"Biomedicines","studyType":"Clinical Study"},{"pmid":"41895523","year":"2026","title":"Ntimicrobial-resistant Listeria species isolated from beef and beef products sold in Mpumalanga province, South Africa.","finding":"","journal":"Journal of food protection","studyType":"Clinical Study"},{"pmid":"41892484","year":"2026","title":"Antimicrobial Resistance and ESBL-Associated Predictors Among Uropathogens: A 2019-2024 Isolate-Level Study.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41890377","year":"2026","title":"Assessment of Antibiotic Prescribing Patterns Among Dentists and their Impact on Antimicrobial Resistance in Oral Infections.","finding":"","journal":"Journal of pharmacy & bioallied sciences","studyType":"Clinical Study"},{"pmid":"41874364","year":"2026","title":"Piperacillin-tazobactam resistance in Klebsiella pneumoniae is often associated with IS26-mediated bla(SHV-1) amplification in a widespread Klebsiella-adapted plasmid.","finding":"","journal":"Antimicrobial agents and chemotherapy","studyType":"Clinical Study"}],"tags":[{"label":"beta Lactamase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Oral","category":"route"},{"label":"For Suspension","category":"form"},{"label":"Powder","category":"form"},{"label":"Suspension","category":"form"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Acute bacterial sinusitis","category":"indication"},{"label":"Bacterial infection due to Klebsiella pneumoniae","category":"indication"},{"label":"Bacterial pneumonia","category":"indication"},{"label":"Bacterial septicemia","category":"indication"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Bacteroides Endometritis","category":"indication"},{"label":"Dr Reddys Labs Inc","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"beta-Lactamase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":172.347,"date":"","count":111,"signal":"Hepatocellular injury","source":"DrugCentral FAERS","actionTaken":"Reported 111 times (LLR=172)"},{"llr":167.147,"date":"","count":114,"signal":"Cholestasis","source":"DrugCentral FAERS","actionTaken":"Reported 114 times (LLR=167)"},{"llr":154.335,"date":"","count":69,"signal":"Hepatitis cholestatic","source":"DrugCentral FAERS","actionTaken":"Reported 69 times (LLR=154)"},{"llr":144.265,"date":"","count":108,"signal":"Jaundice","source":"DrugCentral FAERS","actionTaken":"Reported 108 times (LLR=144)"},{"llr":99.394,"date":"","count":91,"signal":"Drug reaction with eosinophilia and systemic symptoms","source":"DrugCentral FAERS","actionTaken":"Reported 91 times (LLR=99)"},{"llr":86.609,"date":"","count":102,"signal":"Anaphylactic reaction","source":"DrugCentral FAERS","actionTaken":"Reported 102 times (LLR=87)"},{"llr":86.464,"date":"","count":50,"signal":"Acute generalised exanthematous pustulosis","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=86)"},{"llr":84.13,"date":"","count":53,"signal":"Bone erosion","source":"DrugCentral FAERS","actionTaken":"Reported 53 times (LLR=84)"},{"llr":84.038,"date":"","count":218,"signal":"Drug hypersensitivity","source":"DrugCentral FAERS","actionTaken":"Reported 218 times (LLR=84)"},{"llr":79.852,"date":"","count":64,"signal":"Anaphylactic shock","source":"DrugCentral FAERS","actionTaken":"Reported 64 times (LLR=80)"},{"llr":78.797,"date":"","count":52,"signal":"Toxic skin eruption","source":"DrugCentral FAERS","actionTaken":"Reported 52 times (LLR=79)"},{"llr":78.431,"date":"","count":50,"signal":"Purpura","source":"DrugCentral FAERS","actionTaken":"Reported 50 times (LLR=78)"},{"llr":77.282,"date":"","count":53,"signal":"Bronchiectasis","source":"DrugCentral FAERS","actionTaken":"Reported 53 times (LLR=77)"},{"llr":71.385,"date":"","count":72,"signal":"Rash maculo-papular","source":"DrugCentral FAERS","actionTaken":"Reported 72 times (LLR=71)"},{"llr":68.38,"date":"","count":16,"signal":"Spinal muscular atrophy","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=68)"}],"commonSideEffects":[],"contraindications":["Disease of liver","Infectious mononucleosis","Kidney disease","Obstruction of bile duct","Pseudomembranous enterocolitis"],"specialPopulations":{"Pregnancy":"Reproduction studies performed in pregnant rats and mice given Amoxicillin and Clavulanate Potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to Amoxicillin and Clavulanate Potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately and times the maximum recommended adult human oral dose (875 mg every 12 hours). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.","Geriatric use":"Of the 3,119 patients in an analysis of clinical studies of Amoxicillin and Clavulanate Potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals","Paediatric use":"The safety and effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of Amoxicillin and Clavulanate Potassium in pediatric patients is supported by evidence from studies of Amoxicillin and Clavulanate Potassium Tablets in adults with additional data from study of Amoxicillin and Clavulanate Potassium for Oral Suspension in pediatric patients aged 3 months to 12 years with acute otitis media","Renal impairment":"Dosage adjustment is recommended for severe renal impairment (GFR< 30mL/min)"}},"trials":[],"aliases":[],"company":"Dr Reddys Labs Inc","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CLAVULANIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:39:22.922256+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:39:29.687414+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLAVULANIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:39:30.415430+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL777/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:39:31.530666+00:00"}},"allNames":"augmentin 250","offLabel":[],"synonyms":["clavulanic acid","clavulanate","clavulanate potassium","clavulante potasium","clavulanate potassium salt"],"timeline":[{"date":"1984-08-06","type":"positive","source":"DrugCentral","milestone":"FDA approval (Dr Reddys Labs Inc)"}],"aiSummary":"Augmentin 250 (Clavulanate) is a beta-lactamase inhibitor developed by Dr. Reddy's Labs Inc. It is a small molecule modality that works by inhibiting bacterial beta-lactamase enzymes, thereby enhancing the effectiveness of penicillin-class antibiotics. Augmentin 250 is approved to treat various bacterial infections, including sinusitis, pneumonia, and urinary tract infections. It has been FDA-approved since 1984 and is currently owned by Dr. Reddy's Labs Inc. Key safety considerations include its short half-life of 0.9 hours and moderate bioavailability of 75%.","approvals":[{"date":"1984-08-06","orphan":false,"company":"DR REDDYS LABS INC","regulator":"FDA"}],"brandName":"Augmentin 250","ecosystem":[{"indication":"Acute bacterial sinusitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Bacterial infection due to Klebsiella pneumoniae","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"azlocillin","slug":"azlocillin","company":"Bayer Pharmaceuticals Corp"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"}],"globalPrevalence":null},{"indication":"Bacterial pneumonia","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Bacterial septicemia","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azlocillin","slug":"azlocillin","company":"Bayer Pharmaceuticals Corp"}],"globalPrevalence":null},{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"}],"globalPrevalence":null},{"indication":"Bacteroides Endometritis","otherDrugs":[{"name":"cefotaxime","slug":"cefotaxime","company":"Sanofi Aventis Us"},{"name":"cefotetan","slug":"cefotetan","company":""},{"name":"cefoxitin","slug":"cefoxitin","company":""},{"name":"metronidazole","slug":"metronidazole","company":"Gd Searle Llc"}],"globalPrevalence":null},{"indication":"Bacteroides Peritonitis","otherDrugs":[{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"cefotetan","slug":"cefotetan","company":""},{"name":"cefoxitin","slug":"cefoxitin","company":""},{"name":"ceftizoxime","slug":"ceftizoxime","company":""}],"globalPrevalence":null},{"indication":"Citrobacter Urinary Tract Infection","otherDrugs":[{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"},{"name":"cefotaxime","slug":"cefotaxime","company":"Sanofi Aventis Us"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"},{"name":"norfloxacin","slug":"norfloxacin","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","moaClass":"beta Lactamase Inhibitors","modality":"Small Molecule","drugClass":"beta Lactamase Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Augmentin 250, also known as Clavulanate, is a beta-lactamase inhibitor that works by binding to and inhibiting the activity of bacterial beta-lactamase enzymes, thereby preventing the hydrolysis of beta-lactam antibiotics and enhancing their antibacterial efficacy."},"commercial":{"launchDate":"1984","_launchSource":"DrugCentral (FDA 1984-08-06, DR REDDYS LABS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/669","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CLAVULANIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLAVULANIC ACID","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:05:49.462219","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:39:33.456069+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"imipenem","drugSlug":"imipenem","fdaApproval":"1985-11-26","relationship":"same-target"},{"drugName":"sulbactam","drugSlug":"sulbactam","fdaApproval":"1986-12-31","relationship":"same-target"},{"drugName":"tazobactam","drugSlug":"tazobactam","fdaApproval":"1993-10-22","relationship":"same-target"}],"genericName":"clavulanic acid","indications":{"approved":[{"name":"Acute bacterial sinusitis","source":"DrugCentral","snomedId":75498004,"regulator":"FDA"},{"name":"Bacterial infection due to Klebsiella pneumoniae","source":"DrugCentral","snomedId":186435004,"regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Bacterial pneumonia","source":"DrugCentral","snomedId":53084003,"regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Bacterial septicemia","source":"DrugCentral","snomedId":10001005,"regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Bacterial urinary infection","source":"DrugCentral","snomedId":312124009,"regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Bacteroides Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Bacteroides Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Citrobacter Urinary Tract Infection","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"E. Coli Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"E. Coli Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"Adults and pediatric patients"},{"name":"Enterobacter Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Escherichia coli urinary tract infection","source":"DrugCentral","snomedId":301011002,"regulator":"FDA"},{"name":"Haemophilus Influenzae Acute Otitis Media","source":"DrugCentral","snomedId":19021002,"regulator":"FDA"},{"name":"Haemophilus Parainfluenzae Pneumonia","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Haemophilus influenzae pneumonia","source":"DrugCentral","snomedId":70036007,"regulator":"FDA"},{"name":"Infection due to Escherichia coli","source":"DrugCentral","snomedId":71057007,"regulator":"FDA"},{"name":"Infection due to Staphylococcus aureus","source":"DrugCentral","snomedId":406602003,"regulator":"FDA"},{"name":"Infection of skin AND/OR subcutaneous tissue","source":"DrugCentral","snomedId":19824006,"regulator":"FDA"},{"name":"Infective otitis media","source":"DrugCentral","snomedId":312218008,"regulator":"FDA"},{"name":"Klebsiella Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella Pneumoniae Peritonitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Klebsiella cystitis","source":"DrugCentral","snomedId":60867007,"regulator":"FDA"},{"name":"Moraxella Catarrhalis Acute Otitis Media","source":"DrugCentral","snomedId":703469002,"regulator":"FDA","usPrevalence":null,"globalPrevalence":709000000,"prevalenceMethod":"curated","prevalenceSource":"Influenza Other Respir Viruses, 2026 (PMID:41640273)"},{"name":"Moraxella Catarrhalis Pneumonia","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Osteomyelitis due to Staphylococcus aureus","source":"DrugCentral","snomedId":428783003,"regulator":"FDA"},{"name":"Pneumococcal Acute Otitis Media","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Pneumococcal pneumonia","source":"DrugCentral","snomedId":233607000,"regulator":"FDA"},{"name":"Pneumonia due to Klebsiella pneumoniae","source":"DrugCentral","snomedId":64479007,"regulator":"FDA"},{"name":"Pneumonia due to Staphylococcus aureus","source":"DrugCentral","snomedId":441658007,"regulator":"FDA"},{"name":"Pseudomonas Aeruginosa Urinary Tract Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Rhinoscleroma","source":"DrugCentral","snomedId":72409005,"regulator":"FDA"},{"name":"Sepsis due to Pseudomonas","source":"DrugCentral","snomedId":448813005,"regulator":"FDA"},{"name":"Sepsis due to Staphylococcus aureus","source":"DrugCentral","snomedId":448417001,"regulator":"FDA"},{"name":"Septicemia due to Escherichia coli","source":"DrugCentral","snomedId":9323009,"regulator":"FDA"},{"name":"Serratia Urinary Tract Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Staphylococcal pneumonia","source":"DrugCentral","snomedId":22754005,"regulator":"FDA"},{"name":"Staphylococcus Aureus Joint Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Staphylococcus Aureus Urinary Tract Infection","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Staphylococcus Endometritis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Urinary tract infectious disease","source":"DrugCentral","snomedId":68566005,"regulator":"FDA"}],"offLabel":[{"name":"Acute exacerbation of chronic bronchitis","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":87,"evidenceLevel":"strong"},{"name":"Acute otitis media","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":278,"evidenceLevel":"strong"},{"name":"Cat bite - wound","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":19,"evidenceLevel":"moderate"},{"name":"Chancroid","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":11,"evidenceLevel":"moderate"},{"name":"Cholangitis","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":16,"evidenceLevel":"moderate"},{"name":"Chronic purulent otitis media","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":22,"evidenceLevel":"moderate"},{"name":"Diabetic Foot Infection","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":48,"evidenceLevel":"moderate"},{"name":"Diverticulitis of gastrointestinal tract","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":3,"evidenceLevel":"emerging"},{"name":"Dog bite - wound","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":39,"evidenceLevel":"moderate"},{"name":"Human bite - wound","source":"DrugCentral","drugName":"CLAVULANIC ACID","evidenceCount":27,"evidenceLevel":"moderate"},{"name":"Pseudomonas Respiratory Tract Infection in Cystic Fibrosis","source":"DrugCentral","drugName":"CLAVULANIC ACID"},{"name":"Pyrexia of unknown origin","source":"DrugCentral","drugName":"CLAVULANIC ACID"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"imipenem","brandName":"imipenem","genericName":"imipenem","approvalYear":"1985","relationship":"same-target"},{"drugId":"sulbactam","brandName":"sulbactam","genericName":"sulbactam","approvalYear":"1986","relationship":"same-target"},{"drugId":"tazobactam","brandName":"tazobactam","genericName":"tazobactam","approvalYear":"1993","relationship":"same-target"}],"trialDetails":[{"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,"completionDate":"2028-10-01"},{"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,"completionDate":"2027-12"},{"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,"completionDate":"2028-09"},{"nctId":"NCT07322549","phase":"","title":"Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management","status":"COMPLETED","sponsor":"Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer","startDate":"2025-03-01","conditions":["Severe Community-acquired Pneumonia"],"enrollment":104,"completionDate":"2025-09-30"},{"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,"completionDate":"2026-06"},{"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,"completionDate":"2028-12"},{"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,"completionDate":"2028-05"},{"nctId":"NCT06537609","phase":"NA","title":"A Platform Trial for Gram Negative Bloodstream Infections","status":"RECRUITING","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2024-04-24","conditions":["Gram-negative Bacteremia"],"enrollment":2500,"completionDate":"2028-04"},{"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,"completionDate":"2028-01-01"},{"nctId":"NCT07364253","phase":"NA","title":"'Propolis Versus Chlorhexidine Gluconate on Wound Healing After Third Molar Surgery: a Randomized Controlled Trial'","status":"COMPLETED","sponsor":"Ataturk University","startDate":"2021-01-05","conditions":["Third Molar Surgery","Post Operative Analgesia"],"enrollment":52,"completionDate":"2022-01-07"},{"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,"completionDate":"2027-05-25"},{"nctId":"NCT07030673","phase":"NA","title":"Early Discontinuation of Antibiotic Therapy in Elderly Patients Hospitalized for a Viral Infection","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2025-02-14","conditions":["Elderly","Antibiotics Overuse","Viral Infections","PCR Multiplex"],"enrollment":256,"completionDate":"2027-06"},{"nctId":"NCT02456974","phase":"","title":"Antibiotic Dosing in Pediatric Intensive Care","status":"RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2012-05","conditions":["Pharmacokinetics","Amoxicillin-clavulanate","Piperacillin-tazobactam","Vancomycin","Teicoplanin","Meropenem","Ciprofloxacin","Amikacin"],"enrollment":640,"completionDate":"2027-09-01"},{"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","Meropenem","Cefazolin","Teicoplanin","Vancomycin","Ciprofloxacin","Amikacin"],"enrollment":300,"completionDate":"2026-07-01"},{"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,"completionDate":"2022-12"},{"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,"completionDate":"2023-01-22"},{"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,"completionDate":"2026-07-31"},{"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,"completionDate":"2024-04-12"},{"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,"completionDate":"2019-11-19"},{"nctId":"NCT01388413","phase":"PHASE4","title":"Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2011-08","conditions":["Neurogenic Bladder","Urinary Tract Infection"],"enrollment":45,"completionDate":"2017-02"},{"nctId":"NCT07236944","phase":"PHASE4","title":"Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care","status":"RECRUITING","sponsor":"Uppsala University","startDate":"2025-12","conditions":["Febrile Urinary Tract Infection"],"enrollment":560,"completionDate":"2029-03"},{"nctId":"NCT06294600","phase":"PHASE3","title":"Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)","status":"RECRUITING","sponsor":"Hellenic Institute for the Study of Sepsis","startDate":"2024-02-12","conditions":["Community-acquired Pneumonia"],"enrollment":330,"completionDate":"2026-07-30"},{"nctId":"NCT07269171","phase":"NA","title":"The Effect of Supplementary Foods Containing Trypsin, Chymotrypsin and Serratia Peptidase on Healing After Impacted Wisdom Tooth Surgery","status":"NOT_YET_RECRUITING","sponsor":"Saglik Bilimleri Universitesi","startDate":"2025-12-01","conditions":["Oral Health Care"],"enrollment":15,"completionDate":"2026-03-10"},{"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","Pharmacokinetic","Amoxicillin"],"enrollment":11,"completionDate":"2025-12-01"},{"nctId":"NCT07234448","phase":"NA","title":"Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use","status":"NOT_YET_RECRUITING","sponsor":"Liaquat University of Medical & Health Sciences","startDate":"2025-12-01","conditions":["Antibiotic-associated Diarrhea"],"enrollment":1000,"completionDate":"2026-05-29"},{"nctId":"NCT05840588","phase":"NA","title":"Effect of Bifidobacterium Breve PRL2020 (an Amoxicillin-clavulanate-resistant Strain) on Gastrointestinal Symptoms and Gut Microbiota Composition in Children Treated With Amoxicillin or Amoxicillin/Clavulanate","status":"COMPLETED","sponsor":"Liaquat University of Medical & Health Sciences","startDate":"2023-11-06","conditions":["Bacterial Infections"],"enrollment":121,"completionDate":"2025-04-18"},{"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,"completionDate":"2012-04-01"},{"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,"completionDate":"2025-08-01"},{"nctId":"NCT03713424","phase":"PHASE2","title":"An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction","status":"RECRUITING","sponsor":"University of Missouri-Columbia","startDate":"2019-03-26","conditions":["Tobacco Use Disorder"],"enrollment":30,"completionDate":"2026-08-31"},{"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","Infection, Bacterial","Anti-bacterial Agents"],"enrollment":72,"completionDate":"2027-08-01"},{"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&#39;s Lymphoma"],"enrollment":900,"completionDate":"2027-03-31"},{"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,"completionDate":"2027-03-31"},{"nctId":"NCT07104370","phase":"NA","title":"Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws","status":"RECRUITING","sponsor":"Semmelweis University","startDate":"2025-09-29","conditions":["Edentulous Alveolar Ridge","Edentulous Alveolar Ridge Atrophy"],"enrollment":30,"completionDate":"2033-09-01"},{"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","Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days"],"enrollment":414,"completionDate":"2012-11"},{"nctId":"NCT06443502","phase":"PHASE3","title":"A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis","status":"RECRUITING","sponsor":"Takeda","startDate":"2024-11-19","conditions":["Pouchitis"],"enrollment":30,"completionDate":"2029-12-31"},{"nctId":"NCT06055257","phase":"PHASE3","title":"Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible","status":"RECRUITING","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2025-01-16","conditions":["Osteoradionecrosis","Osteoradionecrosis of Jaw","Osteoradionecrosis of the Mandible"],"enrollment":24,"completionDate":"2027-12"},{"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","Pulmonary Infection","Gastrointestinal Infection","Genitourinary Infection"],"enrollment":94,"completionDate":"2025-02-14"},{"nctId":"NCT07082465","phase":"","title":"Epidemiology of Antimicrobial-use and Antimicrobial-resistant Infections in Four Hospitals in Thailand","status":"NOT_YET_RECRUITING","sponsor":"University of Oxford","startDate":"2025-08-01","conditions":["Drug Resistance","Bacterial","Bacteremia"],"enrollment":108000,"completionDate":"2026-08-16"},{"nctId":"NCT06804096","phase":"PHASE4","title":"Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)","status":"RECRUITING","sponsor":"Dr. Md. Alimur Reza","startDate":"2025-02-20","conditions":["Pneumonia, Community-Acquired","Bacterial Pneumonia"],"enrollment":160,"completionDate":"2025-12-01"},{"nctId":"NCT04198129","phase":"PHASE1","title":"The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures","status":"TERMINATED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2020-10-01","conditions":["Jaw Fractures","Infection"],"enrollment":13,"completionDate":"2022-03-20"},{"nctId":"NCT03369717","phase":"PHASE4","title":"Use of Perioperative Antibiotics in Endoscopic Sinus Surgery","status":"TERMINATED","sponsor":"Montefiore Medical Center","startDate":"2018-08-01","conditions":["Chronic Sinus Infection"],"enrollment":24,"completionDate":"2020-05-07"},{"nctId":"NCT02570347","phase":"PHASE4","title":"Routine Antibiotic vs. Directed Antibiotic Treatment in Snake Bite","status":"TERMINATED","sponsor":"Jawaharlal Institute of Postgraduate Medical Education & Research","startDate":"2016-05-03","conditions":["Snake Bites"],"enrollment":66,"completionDate":"2020-03-31"},{"nctId":"NCT03130452","phase":"PHASE4","title":"Helicobacter Pylori Eradication Study","status":"COMPLETED","sponsor":"Inje University","startDate":"2016-12-17","conditions":["Helicobacter Pylori Infection"],"enrollment":423,"completionDate":"2019-05-31"},{"nctId":"NCT06953271","phase":"PHASE4","title":"Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection","status":"NOT_YET_RECRUITING","sponsor":"Women and Infants Hospital of Rhode Island","startDate":"2025-05-15","conditions":["Overactive Bladder (OAB)","Urinary Tract Infection (Diagnosis)"],"enrollment":164,"completionDate":"2027-01-01"},{"nctId":"NCT06929702","phase":"PHASE4","title":"Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2025-04-22","conditions":["Amoxicillin-clavulanate","Piperacillin-tazobactam","Meropenem"],"enrollment":58,"completionDate":"2027-10-01"},{"nctId":"NCT04563325","phase":"PHASE4","title":"Oral-only Antibiotics for Bone and Joint Infections in Children","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2020-09-15","conditions":["Osteomyelitis","Septic Arthritis","Bone Infection","Joint Infection","Bone and Joint Infection"],"enrollment":180,"completionDate":"2024-08-05"},{"nctId":"NCT06827496","phase":"","title":"Initial Oral Antibiotics for Bone and Joint Infections in Children","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2024-11-15","conditions":["Osteomyelitis Acute","Septic Arthritis","Bone Infection","Joint Infection","Bone and Joint Infection"],"enrollment":100,"completionDate":"2027-05"},{"nctId":"NCT06895135","phase":"NA","title":"Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children","status":"NOT_YET_RECRUITING","sponsor":"University of Health Sciences Lahore","startDate":"2025-05","conditions":["Acute Otitis Media"],"enrollment":162,"completionDate":"2026-05"},{"nctId":"NCT05340257","phase":"PHASE2","title":"A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2023-10-14","conditions":["Infections, Bacterial"],"enrollment":0,"completionDate":"2024-07-08"},{"nctId":"NCT06850714","phase":"NA","title":"Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid","status":"NOT_YET_RECRUITING","sponsor":"Liaquat University of Medical & Health Sciences","startDate":"2025-02-23","conditions":["Antibiotic Side Effect"],"enrollment":800,"completionDate":"2025-12-31"},{"nctId":"NCT04414722","phase":"EARLY_PHASE1","title":"Mechanisms of Probiotics and Antibiotic-Associated Diarrhea","status":"COMPLETED","sponsor":"Georgetown University","startDate":"2021-01-01","conditions":["Antibiotic-associated Diarrhea"],"enrollment":118,"completionDate":"2023-05-01"},{"nctId":"NCT04048304","phase":"NA","title":"Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial","status":"RECRUITING","sponsor":"Balgrist University Hospital","startDate":"2019-07-31","conditions":["Infection"],"enrollment":236,"completionDate":"2025-12-31"},{"nctId":"NCT05584683","phase":"PHASE1","title":"A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection","status":"COMPLETED","sponsor":"Kaizen Bioscience Co.","startDate":"2023-08-09","conditions":["Pediatric","Bacterial Infections"],"enrollment":39,"completionDate":"2024-12-16"},{"nctId":"NCT02365623","phase":"PHASE2","title":"An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2015-02-18","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":6,"completionDate":"2018-11-08"},{"nctId":"NCT05553743","phase":"","title":"Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2014-03-27","conditions":["Breastfeeding","COVID-19 Infection","COVID-19 Vaccine","Remdesivir","Antibiotics"],"enrollment":5000,"completionDate":"2040-03"},{"nctId":"NCT06787027","phase":"NA","title":"Effect of Manual Massage Technique on Swelling, Pain and Mouth Opening After Bilateral Lower Third Molar Surgery","status":"COMPLETED","sponsor":"Izmir Katip Celebi University","startDate":"2018-03-01","conditions":["Impacted Third Molar Tooth","Swelling/ Edema","Pain","Trismus"],"enrollment":46,"completionDate":"2018-09-01"},{"nctId":"NCT06709196","phase":"PHASE4","title":"Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2025-01-07","conditions":["Cystectomy","Bladder Cancer Requiring Cystectomy","Postoperative Infections","Antibiotic Prophylaxis","Ileal Conduit"],"enrollment":248,"completionDate":"2027-01"},{"nctId":"NCT06020716","phase":"PHASE4","title":"Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study","status":"RECRUITING","sponsor":"Helse Stavanger HF","startDate":"2023-08-16","conditions":["Protracted Bacterial Bronchitis"],"enrollment":350,"completionDate":"2028-04-30"},{"nctId":"NCT05830162","phase":"PHASE4","title":"Oral Antibiotics After Obstetric Perineal Tear","status":"COMPLETED","sponsor":"Hanna Jangö","startDate":"2023-03-21","conditions":["Obstetric Trauma","Infections","Wound Dehiscence"],"enrollment":442,"completionDate":"2024-12-09"},{"nctId":"NCT06533397","phase":"NA","title":"The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation","status":"RECRUITING","sponsor":"Semmelweis University","startDate":"2024-08-24","conditions":["Alveolar Bone Loss","Edentulism Nos"],"enrollment":40,"completionDate":"2031-09"},{"nctId":"NCT05584657","phase":"PHASE3","title":"Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women","status":"COMPLETED","sponsor":"Iterum Therapeutics, International Limited","startDate":"2022-10-18","conditions":["Urinary Tract Infections","Cystitis"],"enrollment":2229,"completionDate":"2023-11-21"},{"nctId":"NCT04803422","phase":"NA","title":"Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis.","status":"COMPLETED","sponsor":"Zealand University Hospital","startDate":"2021-04-01","conditions":["Complicated Appendicitis"],"enrollment":3193,"completionDate":"2024-06-30"},{"nctId":"NCT05893147","phase":"NA","title":"BALANCE+ Vanguard Phase","status":"COMPLETED","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2023-08-26","conditions":["Gram-negative Bacteremia"],"enrollment":174,"completionDate":"2024-08-10"},{"nctId":"NCT06620718","phase":"NA","title":"Evaluation of Root Migration Distance After Coronectomy of Impacted Third Molars","status":"COMPLETED","sponsor":"Mustafa Kemal University","startDate":"2021-01-01","conditions":["Impacted Tooth With Abnormal Positioning"],"enrollment":73,"completionDate":"2022-12-30"},{"nctId":"NCT05753735","phase":"PHASE2","title":"eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF","status":"TERMINATED","sponsor":"Case Comprehensive Cancer Center","startDate":"2024-01-18","conditions":["Pancreatic Fistula"],"enrollment":3,"completionDate":"2024-06-02"},{"nctId":"NCT04436991","phase":"","title":"Antibiotic Dosing in Geriatric Patients At the Emergency Department","status":"RECRUITING","sponsor":"University Hospital, Ghent","startDate":"2018-01-03","conditions":["Elderly Infection","Frailty","Frail Elderly Syndrome","Infection, Bacterial"],"enrollment":180,"completionDate":"2025-01"},{"nctId":"NCT05804123","phase":"NA","title":"LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media","status":"COMPLETED","sponsor":"Anabio R&D","startDate":"2021-10-28","conditions":["Upper Respiratory Tract Infections"],"enrollment":175,"completionDate":"2024-08-01"},{"nctId":"NCT00836901","phase":"PHASE1","title":"Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2003-09","conditions":["Healthy"],"enrollment":52,"completionDate":"2003-09"},{"nctId":"NCT00835705","phase":"PHASE1","title":"Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2003-09","conditions":["Healthy"],"enrollment":52,"completionDate":"2003-09"},{"nctId":"NCT00840840","phase":"PHASE1","title":"600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fed Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2002-08","conditions":["Healthy"],"enrollment":48,"completionDate":"2002-08"},{"nctId":"NCT00840099","phase":"PHASE1","title":"600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2002-08","conditions":["Healthy"],"enrollment":48,"completionDate":"2002-08"},{"nctId":"NCT04755179","phase":"","title":"Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population","status":"COMPLETED","sponsor":"Ramon Gorter","startDate":"2019-08-12","conditions":["Appendicitis","Appendix Mass","Appendicitis Perforated"],"enrollment":1308,"completionDate":"2024-07-03"},{"nctId":"NCT05867654","phase":"PHASE4","title":"Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis","status":"NOT_YET_RECRUITING","sponsor":"University of Louisville","startDate":"2024-07-31","conditions":["Osteomyelitis of Jaw"],"enrollment":100,"completionDate":"2025-12"},{"nctId":"NCT06502288","phase":"NA","title":"Evaluation of Antibiotic Administration Following Tooth Extraction","status":"NOT_YET_RECRUITING","sponsor":"Chittagong Medical College","startDate":"2025-01-01","conditions":["Tooth Extraction"],"enrollment":152,"completionDate":"2025-10-15"},{"nctId":"NCT02735707","phase":"PHASE3","title":"Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia","status":"RECRUITING","sponsor":"UMC Utrecht","startDate":"2016-04-11","conditions":["Community-acquired Pneumonia, Influenza, COVID-19"],"enrollment":20000,"completionDate":"2028-02"},{"nctId":"NCT05819229","phase":"","title":"Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2023-02-27","conditions":["Urinary Tract Infections in Children"],"enrollment":125,"completionDate":"2025-05-01"},{"nctId":"NCT04041791","phase":"PHASE3","title":"A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2019-08-19","conditions":["Pneumonia"],"enrollment":4392,"completionDate":"2024-04-05"},{"nctId":"NCT06458478","phase":"NA","title":"Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery","status":"RECRUITING","sponsor":"Azienda Ospedaliera di Perugia","startDate":"2024-07-01","conditions":["Molar, Fourth","Extracting Own Teeth","Edema Face","Pain","Trismus"],"enrollment":72,"completionDate":"2025-02-01"},{"nctId":"NCT06277609","phase":"PHASE1","title":"A Trial Investigating Lu AF28996 in Healthy Adult Participants","status":"COMPLETED","sponsor":"H. Lundbeck A/S","startDate":"2024-02-27","conditions":["Healthy Participants"],"enrollment":22,"completionDate":"2024-05-19"},{"nctId":"NCT04600752","phase":"PHASE4","title":"Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-05-07","conditions":["Otitis Media","Infections, Respiratory Tract","Respiratory Tract Infections"],"enrollment":310,"completionDate":"2022-11-12"},{"nctId":"NCT00423176","phase":"PHASE3","title":"The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)","status":"TERMINATED","sponsor":"Organon and Co","startDate":"2006-12","conditions":["Sinusitis"],"enrollment":237,"completionDate":"2008-06"},{"nctId":"NCT05169554","phase":"PHASE2","title":"Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy","status":"RECRUITING","sponsor":"Fundacion Agencia Aragonesa para la Investigacion y Desarrollo (ARAID)","startDate":"2021-12-01","conditions":["Buruli Ulcer"],"enrollment":140,"completionDate":"2026-05-31"},{"nctId":"NCT05562349","phase":"PHASE2","title":"Clavulanic Acid for the Treatment of Cocaine Use Disorder","status":"ACTIVE_NOT_RECRUITING","sponsor":"Temple University","startDate":"2023-05-03","conditions":["Cocaine Dependence"],"enrollment":65,"completionDate":"2024-07"},{"nctId":"NCT05678621","phase":"PHASE2,PHASE3","title":"Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension","status":"RECRUITING","sponsor":"Monash University","startDate":"2022-11-30","conditions":["Haematological Malignancy","Hypogammaglobulinemia"],"enrollment":300,"completionDate":"2027-04"},{"nctId":"NCT04573504","phase":"PHASE4","title":"Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair","status":"RECRUITING","sponsor":"Northwestern University","startDate":"2020-09-23","conditions":["Vaginal Laceration During Delivery"],"enrollment":274,"completionDate":"2024-12-31"},{"nctId":"NCT05519072","phase":"PHASE4","title":"Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA","status":"RECRUITING","sponsor":"Atlantic Health System","startDate":"2022-08-16","conditions":["Antibiotic Prophylaxis"],"enrollment":140,"completionDate":"2024-08-16"},{"nctId":"NCT03795194","phase":"PHASE4","title":"Antibiotic Duration in Post-appendectomy Abscess","status":"TERMINATED","sponsor":"Phoenix Children's Hospital","startDate":"2019-05-01","conditions":["Complicated Appendicitis","Perforated Appendicitis"],"enrollment":7,"completionDate":"2021-12-15"},{"nctId":"NCT05999955","phase":"NA","title":"Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis","status":"COMPLETED","sponsor":"Huro Biotech Joint Stock Company","startDate":"2022-12-29","conditions":["Rhinosinusitis","Rhinitis"],"enrollment":60,"completionDate":"2023-05-25"},{"nctId":"NCT06250413","phase":"NA","title":"Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics","status":"NOT_YET_RECRUITING","sponsor":"Otto Helve","startDate":"2024-02","conditions":["Microbial Colonization","Antibiotic Side Effect"],"enrollment":40,"completionDate":"2027-12"},{"nctId":"NCT03897582","phase":"","title":"Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy: the BLIPIC Study","status":"RECRUITING","sponsor":"Centre Hospitalier de Valenciennes","startDate":"2019-02-22","conditions":["Beta-lactam","Continuous Renal Replacement Therapy","Pneumonia","Antibiotic"],"enrollment":65,"completionDate":"2026-05-31"},{"nctId":"NCT05248620","phase":"NA","title":"Prophylactic Antibiotic Treatment in Hemodialysis","status":"RECRUITING","sponsor":"Zealand University Hospital","startDate":"2022-02-14","conditions":["Hemodialysis"],"enrollment":800,"completionDate":"2029-05"},{"nctId":"NCT06193837","phase":"","title":"Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2024-01-01","conditions":["Cholecystectomy, Laparoscopic"],"enrollment":200,"completionDate":"2026-01-01"},{"nctId":"NCT04724044","phase":"PHASE3","title":"Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia","status":"COMPLETED","sponsor":"Hellenic Institute for the Study of Sepsis","startDate":"2021-01-25","conditions":["Community-acquired Pneumonia","Sepsis","Inflammatory Response","Mortality","Biomarkers","SIRS"],"enrollment":278,"completionDate":"2023-04-11"},{"nctId":"NCT06154720","phase":"","title":"Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2022-09-10","conditions":["Surgical Site Infection"],"enrollment":200,"completionDate":"2023-06-29"},{"nctId":"NCT02563769","phase":"PHASE1","title":"Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study","status":"COMPLETED","sponsor":"Temple University","startDate":"2016-10-24","conditions":["Cocaine Dependence","Cocaine Addiction","Cocaine Abuse","Cocaine-Related Disorders"],"enrollment":10,"completionDate":"2018-05-25"},{"nctId":"NCT03508921","phase":"PHASE4","title":"Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection","status":"TERMINATED","sponsor":"Vanderbilt University Medical Center","startDate":"2018-07-01","conditions":["Overactive Bladder","Urinary Tract Infections"],"enrollment":22,"completionDate":"2022-06-01"},{"nctId":"NCT03333408","phase":"PHASE4","title":"Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement","status":"UNKNOWN","sponsor":"Our Lady of the Lake Hospital","startDate":"2018-06-15","conditions":["Salivary Duct"],"enrollment":40,"completionDate":"2024-12-31"},{"nctId":"NCT02848820","phase":"PHASE4","title":"Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children","status":"UNKNOWN","sponsor":"Ramon Gorter","startDate":"2016-12","conditions":["Appendicitis"],"enrollment":302,"completionDate":"2024-12"},{"nctId":"NCT00917592","phase":"PHASE4","title":"Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis","status":"COMPLETED","sponsor":"Consorci Sanitari de Terrassa","startDate":"2005-12","conditions":["Diverticulitis"],"enrollment":50,"completionDate":"2008-10"},{"nctId":"NCT02021006","phase":"PHASE3","title":"Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract","status":"UNKNOWN","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","startDate":"2013-12","conditions":["Vesicoureteral Reflux","Renal Hypodysplasia, Nonsyndromic, 1","Chronic Kidney Disease"],"enrollment":292,"completionDate":"2025-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"For Suspension, Powder, Suspension, Tablet","formulations":[{"form":"FOR SUSPENSION","route":"ORAL","productName":"AUGMENTIN ES-600"},{"form":"FOR SUSPENSION","route":"ORAL","productName":"Augmentin"},{"form":"FOR SUSPENSION","route":"ORAL","productName":"AMOXICILLIN AND CLAVULANATE POTASSIUM"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"AUGMENTIN"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"Amoxicillin"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"Amoxicillin and Clavulanate Potassium"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"Amoxicillin/Clav Pot Oral Susp"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"AMOXICILLIN AND CLAVULANATE POTASSIUM"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"AUGMENTIN"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"AUGMENTIN ES-600"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"Amoxicillin and Clavulanate Potassium"},{"form":"POWDER, FOR SUSPENSION","route":"ORAL","productName":"amoxicillin and clavulanate potassium"},{"form":"SUSPENSION","route":"ORAL","productName":"Amoxicillin and Clavulanate Potassium"},{"form":"SUSPENSION","route":"ORAL","productName":"amoxicillin and clavulanate potassium"},{"form":"TABLET","route":"ORAL","productName":"AMOXICILLIN/CLAV POT"}]},"crossReferences":{"NUI":"N0000005804","MMSL":"4463","NDDF":"002808","UNII":"23521W1S24","CHEBI":"CHEBI:48947","VANDF":"4018406","INN_ID":"4948","RXNORM":"21216","UMLSCUI":"C0055860","chemblId":"CHEMBL777","ChEMBL_ID":"CHEMBL777","KEGG_DRUG":"D02370","DRUGBANK_ID":"DB00766","PDB_CHEM_ID":" J01","PUBCHEM_CID":"5280980","SNOMEDCT_US":"395938000","IUPHAR_LIGAND_ID":"11128","SECONDARY_CAS_RN":"61177-45-5","MESH_DESCRIPTOR_UI":"D019818"},"formularyStatus":[],"originalProduct":{"form":"TABLET, FILM COATED, EXTENDED RELEASE","route":"ORAL","company":"Dr. Reddys Laboratories Inc","brandName":"Amoxicillin and Clavulanate Potassium Extended Release","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1984-","companyName":"Dr Reddys Labs Inc","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"0.9 hours","clearance":"3.1 mL/min/kg","bioavailability":"75%","fractionUnbound":"0.91%","volumeOfDistribution":"0.22 L/kg"},"publicationCount":7185,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"originalDeveloper":"Dr Reddys Labs Inc","recentPublications":[{"date":"2026 Feb 25","pmid":"41898147","title":"Comparative Evaluation of Amoxicillin-Clavulanate and Ertapenem in an Exploratory Rat Model of ESBL E. coli Peritonitis.","journal":"Biomedicines"},{"date":"2026 Mar 25","pmid":"41895523","title":"Ntimicrobial-resistant Listeria species isolated from beef and beef products sold in Mpumalanga province, South Africa.","journal":"Journal of food protection"},{"date":"2026 Mar 23","pmid":"41892484","title":"Antimicrobial Resistance and ESBL-Associated Predictors Among Uropathogens: A 2019-2024 Isolate-Level Study.","journal":"Antibiotics (Basel, Switzerland)"},{"date":"2026 Jan-Mar","pmid":"41890377","title":"Assessment of Antibiotic Prescribing Patterns Among Dentists and their Impact on Antimicrobial Resistance in Oral Infections.","journal":"Journal of pharmacy & bioallied sciences"},{"date":"2026 Mar 24","pmid":"41874364","title":"Piperacillin-tazobactam resistance in Klebsiella pneumoniae is often associated with IS26-mediated bla(SHV-1) amplification in a widespread Klebsiella-adapted plasmid.","journal":"Antimicrobial agents and chemotherapy"}],"combinationProducts":[{"brandName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"AUGMENTIN","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"AUGMENTIN ES-600","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"Amoxicillin and Clavulanate Potassium","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"Amoxicillin and Clavulanate Potassium Extended Release","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"Augmentin","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"AugmentinXR","ingredients":"amoxicillin + clavulanic acid"},{"brandName":"amoxicillin and clavulanate potassium","ingredients":"amoxicillin + clavulanic acid"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Dr Reddys Labs Inc","companyId":"dr-reddys-labs-inc","modality":"Small molecule","firstApprovalDate":"1984","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1984-08-06T00:00:00.000Z","mah":"DR REDDYS LABS INC","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","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":"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":"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}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:39:33.456069+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}