{"id":"treatment-with-amikacin","safety":{"commonSideEffects":[{"rate":"8-26","effect":"Nephrotoxicity (acute kidney injury)"},{"rate":"3-14","effect":"Ototoxicity (hearing loss, tinnitus, vertigo)"},{"rate":null,"effect":"Neuromuscular blockade"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Amikacin irreversibly binds to the 30S ribosomal subunit of susceptible bacteria, disrupting accurate mRNA translation and causing misreading of the genetic code. This results in production of non-functional proteins and ultimately bacterial cell death. It is bactericidal and effective against a broad spectrum of gram-negative aerobic bacteria and some gram-positive organisms.","oneSentence":"Amikacin is an aminoglycoside antibiotic that binds to bacterial 30S ribosomal subunits and inhibits protein synthesis, leading to bacterial cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:14:15.000Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Serious gram-negative bacterial infections"},{"name":"Nosocomial infections caused by susceptible organisms"},{"name":"Septicemia"},{"name":"Respiratory tract infections"},{"name":"Urinary tract infections"},{"name":"Intra-abdominal infections"}]},"trialDetails":[{"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":"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":"NCT05730283","phase":"PHASE2","title":"Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin","status":"RECRUITING","sponsor":"Kevin Winthrop","startDate":"2025-06-02","conditions":"Ototoxicity, Drug-Induced","enrollment":105},{"nctId":"NCT05227937","phase":"","title":"Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study","status":"RECRUITING","sponsor":"Antonios Likourezos","startDate":"2022-09-21","conditions":"Urinary Tract Infections","enrollment":75},{"nctId":"NCT07369336","phase":"PHASE4","title":"Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia","status":"COMPLETED","sponsor":"Postgraduate Medical Institute, Lahore","startDate":"2024-01-05","conditions":"Ventilator Associated Pneumonia ( VAP)","enrollment":90},{"nctId":"NCT07315438","phase":"NA","title":"Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children","status":"COMPLETED","sponsor":"Hacettepe University","startDate":"2023-12-01","conditions":"Model Informed Precision Dosing","enrollment":41},{"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},{"nctId":"NCT04178148","phase":"NA","title":"Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2019-11-25","conditions":"Shock, Septic","enrollment":180},{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":"HIV Infections","enrollment":1578},{"nctId":"NCT02898961","phase":"PHASE4","title":"Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2014-10","conditions":"Sepsis","enrollment":63},{"nctId":"NCT06585020","phase":"PHASE2","title":"Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2024-10-20","conditions":"Mycobacterium; Xenopi, Lung Diseases","enrollment":190},{"nctId":"NCT06418711","phase":"PHASE3","title":"ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension","status":"TERMINATED","sponsor":"Mannkind Corporation","startDate":"2024-09-11","conditions":"MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous","enrollment":132},{"nctId":"NCT03825874","phase":"","title":"Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children","status":"RECRUITING","sponsor":"Centre Hospitalier Intercommunal Creteil","startDate":"2019-01-19","conditions":"Urinary Tract Infections, Urinary Tract Infections in Children","enrollment":200},{"nctId":"NCT04310930","phase":"PHASE2, PHASE3","title":"Finding the Optimal Regimen for Mycobacterium Abscessus Treatment","status":"RECRUITING","sponsor":"The University of Queensland","startDate":"2020-03-02","conditions":"Pulmonary Disease Due to Mycobacteria (Diagnosis)","enrollment":300},{"nctId":"NCT07089186","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-04-12","conditions":"Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI)","enrollment":80},{"nctId":"NCT06051513","phase":"NA","title":"Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection","status":"RECRUITING","sponsor":"Southeast University, China","startDate":"2023-11-27","conditions":"Carbapenem-Resistant Enterobacteriaceae Infection","enrollment":404},{"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},{"nctId":"NCT05929599","phase":"NA","title":"Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Children's Hospital, Vietnam","startDate":"2023-07-05","conditions":"Acute Respiratory Tract Infections, Pneumonia, Respiratory Syncytial Virus (RSV)","enrollment":120},{"nctId":"NCT06739382","phase":"PHASE3","title":"Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center","status":"COMPLETED","sponsor":"Beni-Suef University","startDate":"2021-01-01","conditions":"Ventilation Acquired Pneumonia","enrollment":64},{"nctId":"NCT06419296","phase":"","title":"Mortality of MBL-producing Enterobacteriaceae Bacteremias with the Combined Use of Ceftazidime-avibactam and Aztreonam Vs. Other Active Antibiotics. a Multicenter Target Trial Emulation.","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2024-06-01","conditions":"Bacteremia","enrollment":265},{"nctId":"NCT03867136","phase":"PHASE4","title":"Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2020-06-01","conditions":"Multidrug Resistant Tuberculosis","enrollment":354},{"nctId":"NCT04882085","phase":"PHASE4","title":"Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-08-26","conditions":"Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia","enrollment":60},{"nctId":"NCT06106789","phase":"","title":"A Study of the Clinical Benefit of Tobramycin Inhalation Solution","status":"ACTIVE_NOT_RECRUITING","sponsor":"Qianfoshan Hospital","startDate":"2023-04-01","conditions":"Bronchiectasis, Cystic Fibrosis, Lung Infection","enrollment":1600},{"nctId":"NCT06602557","phase":"PHASE2","title":"\" a Randomized Pilot Study of the Benefit of Nebulized Amikacin in the Treatment of Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-arterial Oxygenation (ECMO-VA).\"","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2024-11-15","conditions":"Pneumonia, Bacterial, Extracorporeal Membrane Oxygenation","enrollment":26},{"nctId":"NCT02872272","phase":"PHASE4","title":"Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population","status":"TERMINATED","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2020-01-06","conditions":"Burn Patients","enrollment":7},{"nctId":"NCT05689450","phase":"","title":"Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2022-12-21","conditions":"Febrile Neutropenia (FN)","enrollment":92},{"nctId":"NCT06261164","phase":"","title":"Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients","status":"UNKNOWN","sponsor":"University Clinical Centre of Republic of Srpska","startDate":"2024-01-31","conditions":"Sepsis","enrollment":20},{"nctId":"NCT05761405","phase":"EARLY_PHASE1","title":"Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire Vaudois","startDate":"2024-01-16","conditions":"Urinary Tract Infections, Urological System Complication of Procedure","enrollment":90},{"nctId":"NCT06097767","phase":"EARLY_PHASE1","title":"the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy","status":"UNKNOWN","sponsor":"Al-Azhar University","startDate":"2023-10-19","conditions":"Pharmacological Action of Drug","enrollment":50},{"nctId":"NCT03237182","phase":"PHASE4","title":"The Individualized M(X) Drug-resistant TB Treatment Strategy Study","status":"TERMINATED","sponsor":"Centre for the AIDS Programme of Research in South Africa","startDate":"2017-06-14","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":205},{"nctId":"NCT04035369","phase":"NA","title":"Endophthalmitis Post Intravitreal Injections","status":"UNKNOWN","sponsor":"Unity Health Toronto","startDate":"2020-03-01","conditions":"Endophthalmitis","enrollment":310},{"nctId":"NCT05555303","phase":"PHASE2","title":"Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis","status":"UNKNOWN","sponsor":"Rwanda Biomedical Centre","startDate":"2023-03-01","conditions":"Tuberculosis, Multidrug-Resistant","enrollment":20},{"nctId":"NCT03147807","phase":"NA","title":"BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections in ICU","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2017-10-20","conditions":"Pneumonia, Urinary Tract Infections, Bloodstream Infection","enrollment":75},{"nctId":"NCT03990467","phase":"NA","title":"Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU","status":"UNKNOWN","sponsor":"Hospices Civils de Lyon","startDate":"2021-01-28","conditions":"Septic Shock, Sepsis, Sepsis Syndrome","enrollment":60},{"nctId":"NCT05511194","phase":"NA","title":"Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children","status":"UNKNOWN","sponsor":"Instituto Mexicano del Seguro Social","startDate":"2022-10-01","conditions":"Enhanced Recovery After Surgery, Appendicitis, Children, Only","enrollment":40},{"nctId":"NCT04876430","phase":"PHASE2, PHASE3","title":"Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems","status":"TERMINATED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2021-05-04","conditions":"Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection","enrollment":13},{"nctId":"NCT05443854","phase":"PHASE3","title":"Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-09","conditions":"Sepsis, Septic Shock, Hematologic Malignancy","enrollment":340},{"nctId":"NCT03449459","phase":"EARLY_PHASE1","title":"Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract","status":"COMPLETED","sponsor":"Shanghai Zhongshan Hospital","startDate":"2018-12-01","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":144},{"nctId":"NCT04322019","phase":"","title":"Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study","status":"COMPLETED","sponsor":"CHU de Reims","startDate":"2020-05-25","conditions":"Amikacin Treatment","enrollment":112},{"nctId":"NCT02652169","phase":"NA","title":"PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4","status":"RECRUITING","sponsor":"Medical University of Vienna","startDate":"2014-06","conditions":"Chronic Skin Ulcer","enrollment":120},{"nctId":"NCT05213507","phase":"PHASE3","title":"Inhaled Amikacin in Preventing AECOPD","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2022-03","conditions":"COPD, COPD Exacerbation","enrollment":136},{"nctId":"NCT00000796","phase":"NA","title":"A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections, Tuberculosis","enrollment":525},{"nctId":"NCT04132115","phase":"","title":"Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)","status":"UNKNOWN","sponsor":"Azienda Sanitaria-Universitaria Integrata di Udine","startDate":"2019-10-01","conditions":"Therapeutic Drug Monitoring, Subarachnoid Hemorrhage, Intracerebral Hemorrhage","enrollment":104},{"nctId":"NCT04867993","phase":"NA","title":"Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia","status":"UNKNOWN","sponsor":"University of Sarajevo","startDate":"2018-08-28","conditions":"Asphyxia Neonatorum","enrollment":80},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":"Osteomyelitis","enrollment":11},{"nctId":"NCT01316276","phase":"PHASE3","title":"Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2012-10-05","conditions":"Cystic Fibrosis","enrollment":206},{"nctId":"NCT01315678","phase":"PHASE3","title":"Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2012-02-29","conditions":"Pseudomonas Aeruginosa Infection","enrollment":302},{"nctId":"NCT02344004","phase":"PHASE3","title":"Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2015-05-27","conditions":"Mycobacterium Infections, Nontuberculous","enrollment":336},{"nctId":"NCT03038178","phase":"PHASE2","title":"Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease","status":"COMPLETED","sponsor":"Kevin Winthrop","startDate":"2016-10","conditions":"Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical","enrollment":30},{"nctId":"NCT02628600","phase":"PHASE3","title":"Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2016-02-05","conditions":"NTM Lung Infection Due to MAC","enrollment":163},{"nctId":"NCT01315236","phase":"PHASE2","title":"Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria","status":"COMPLETED","sponsor":"Insmed Incorporated","startDate":"2012-04-19","conditions":"Mycobacterium Infections, Nontuberculous","enrollment":90},{"nctId":"NCT03921645","phase":"NA","title":"Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia","status":"UNKNOWN","sponsor":"Shanghai 10th People's Hospital","startDate":"2018-01-01","conditions":"Ventilator Associated Pneumonia, Multi-antibiotic Resistance","enrollment":60},{"nctId":"NCT02081963","phase":"PHASE4","title":"Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis","status":"COMPLETED","sponsor":"Qilu Hospital of Shandong University","startDate":"2014-03","conditions":"Non-Cystic Fibrosis Bronchiectasis","enrollment":178},{"nctId":"NCT00515034","phase":"PHASE2","title":"A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-10","conditions":"Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia","enrollment":146},{"nctId":"NCT02509091","phase":"PHASE4","title":"Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis","status":"UNKNOWN","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2014-12","conditions":"Bronchiectasis","enrollment":100},{"nctId":"NCT03625739","phase":"","title":"Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis","status":"RECRUITING","sponsor":"Beijing Children's Hospital","startDate":"2018-07-01","conditions":"Tuberculosis","enrollment":800},{"nctId":"NCT01315691","phase":"PHASE3","title":"Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa","status":"WITHDRAWN","sponsor":"Insmed Incorporated","startDate":"","conditions":"Cystic Fibrosis","enrollment":""},{"nctId":"NCT03604848","phase":"NA","title":"NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB","status":"UNKNOWN","sponsor":"Huashan Hospital","startDate":"2018-08-05","conditions":"Multidrug Resistant Tuberculosis","enrollment":488},{"nctId":"NCT01799993","phase":"PHASE3","title":"Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-04-13","conditions":"Pneumonia, Bacterial","enrollment":725},{"nctId":"NCT01570192","phase":"PHASE2","title":"Clinical Trials to Reduce the Risk of Antimicrobial Resistance","status":"TERMINATED","sponsor":"University of Florida","startDate":"2010-09","conditions":"Bacterial Pneumonia","enrollment":43},{"nctId":"NCT02975570","phase":"PHASE3","title":"Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin","status":"WITHDRAWN","sponsor":"Boston University","startDate":"2017-08","conditions":"Tuberculosis Multi Drug Resistant Active","enrollment":""},{"nctId":"NCT01969799","phase":"PHASE2","title":"Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia","status":"COMPLETED","sponsor":"Cardeas Pharma","startDate":"2013-12","conditions":"Pneumonia, Bacterial","enrollment":143},{"nctId":"NCT02728518","phase":"NA","title":"Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia","status":"COMPLETED","sponsor":"National Heart Institute, Egypt","startDate":"2014-08","conditions":"Pneumonia","enrollment":133},{"nctId":"NCT02716883","phase":"NA","title":"Early Amniotic Membrane Transplantation in Bacterial Keratitis","status":"UNKNOWN","sponsor":"Farabi Eye Hospital","startDate":"2014-01","conditions":"Keratitis of Both Eyes","enrollment":14},{"nctId":"NCT01021436","phase":"PHASE2","title":"Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-03","conditions":"Pneumonia","enrollment":30},{"nctId":"NCT02218359","phase":"PHASE2","title":"Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization","status":"WITHDRAWN","sponsor":"Cardeas Pharma","startDate":"2014-10","conditions":"Pneumonia, Bacterial","enrollment":""},{"nctId":"NCT00362245","phase":"PHASE4","title":"Amikacin Penetration Into the Cerebrospinal Fluid","status":"WITHDRAWN","sponsor":"Rambam Health Care Campus","startDate":"2006-09","conditions":"Gram Negative Meningitis, Post Traumatic Bacterial Meningitis","enrollment":""},{"nctId":"NCT02120638","phase":"PHASE3","title":"Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide","status":"UNKNOWN","sponsor":"Huashan Hospital","startDate":"2014-04","conditions":"Multidrug Resistant Tuberculosis","enrollment":100},{"nctId":"NCT01867138","phase":"PHASE3","title":"Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2007-03","conditions":"Nosocomial Neonatal Sepsis","enrollment":109},{"nctId":"NCT00950222","phase":"NA","title":"Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2009-06","conditions":"Ventilator Associated Pneumonia","enrollment":70},{"nctId":"NCT00707239","phase":"PHASE2","title":"Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia","status":"TERMINATED","sponsor":"Pfizer","startDate":"2008-12","conditions":"Pneumonia, Bacterial","enrollment":108},{"nctId":"NCT01115153","phase":"NA","title":"Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis","status":"COMPLETED","sponsor":"Universidad Industrial de Santander","startDate":"2007-12","conditions":"Gangrenous Appendicitis","enrollment":150},{"nctId":"NCT01004445","phase":"PHASE2","title":"A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)","status":"COMPLETED","sponsor":"Bayer","startDate":"2005-05","conditions":"Pneumonia","enrollment":69},{"nctId":"NCT00035425","phase":"PHASE3","title":"Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection","status":"COMPLETED","sponsor":"Pfizer","startDate":"2001-11","conditions":"Febrile Neutropenia","enrollment":120},{"nctId":"NCT00360607","phase":"PHASE4","title":"A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2004-07","conditions":"Infection","enrollment":307}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8233,"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":"active","brandName":"Treatment with Amikacin","genericName":"Treatment with Amikacin","companyName":"Assistance Publique Hopitaux De Marseille","companyId":"assistance-publique-hopitaux-de-marseille","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Amikacin is an aminoglycoside antibiotic that binds to bacterial 30S ribosomal subunits and inhibits protein synthesis, leading to bacterial cell death. Used for Serious gram-negative bacterial infections, Nosocomial infections caused by susceptible organisms, Septicemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}