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Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.
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Recruiting Phase 2 Interventional

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

NCT05730283
View directory record Official record
Conditions
Ototoxicity, Drug-Induced
Interventions
ORC-13661, Placebo
Drug
Lead sponsor
Kevin Winthrop
Other
Eligibility
18 Years to 80 Years
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
8
States / cities
San Francisco, California • Denver, Colorado • Baltimore, Maryland + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional

Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease

NCT03038178
View directory record Official record
Conditions
Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical
Interventions
LAI plus multi-drug regimen
Drug
Lead sponsor
Kevin Winthrop
Other
Eligibility
12 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
2
States / cities
Portland, Oregon • Tyler, Texas
Source: ClinicalTrials.gov public record
Updated Mar 3, 2020 · Synced Sep 2, 2026, 5:47 PM EDT
Completed No phase listed Observational Accepts healthy volunteers Results available

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

NCT00042289
View directory record Official record
Conditions
HIV Infections
Interventions
atazanavir/cobicistat, darunavir/ritonavir dosage #1, darunavir/ritonavir dosage #2, darunavir/ritonavir dosage #3, elvitegravir/cobicistat, dolutegravir, tenofovir alafenamide fumarate (TAF), TAF w/cobicistat, TAF w/cobicistat or ritonavir, efavirenz, darunavir/cobicistat, lopinavir/ritonavir dosage #1, atazanavir/ritonavir/tenofovir dosage #1, rifampicin, ethambutol, isoniazid, pyrazinamide, kanamycin, amikacin, capreomycin, moxifloxacin, levoflaxacin, ofloxacin, ethionamide/prothionamide, terizidone/cycloserine, para-aminosalicylic acid (PAS), high dose INH, bedaquiline, clofazamine, delamanid, linezolid, pretomanid, ethinyl estradiol, etonogestrel implant, nevirapine, amprenavir, abacavir, lopinavir/ritonavir dosage #2, indinavir/ritonavir dosage #1, fosamprenavir/ritonavir, lopinavir/ritonavir dosage #3, atazanavir/ritonavir dosage #1, didanosine delayed release (Videx® EC), emtricitabine, tenofovir, nelfinavir dosage #1, tipranavir/ritonavir, lopinavir/ritonavir dosage #4, raltegravir, etravirine, maraviroc, atazanavir/ritonavir dosage #2, tenofovir/atazanavir/ritonavir dosage #2, nelfinavir dosage #2, indinavir/ritonavir dosage #2, rilpivirine, darunavir/ritonavir dosage #4
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Not listed
Enrollment
1,578 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2003 – 2020
U.S. locations
39
States / cities
Birmingham, Alabama • La Jolla, California • Long Beach, California + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 1, 2025 · Synced Sep 2, 2026, 5:47 PM EDT
Completed No phase listed Observational

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

NCT01431326
View directory record Official record
Conditions
Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia
Interventions
The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Drug
Lead sponsor
Daniel Benjamin
Other
Eligibility
Up to 21 Years
Enrollment
3,520 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
43
States / cities
Anchorage, Alaska • Little Rock, Arkansas • La Jolla, California + 37 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2023 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

NCT00558844
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Arikayce™ 560 mg, Placebo for 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg, Placebo for 70 mg / 140 mg
Drug
Lead sponsor
Insmed Incorporated
Industry
Eligibility
6 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • Miami, Florida + 16 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2019 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 3 Interventional Results available

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

NCT04677543
View directory record Official record
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
ALIS, Azithromycin, Ethambutol, ELC
Drug
Lead sponsor
Insmed Incorporated
Industry
Eligibility
18 Years and older
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
27
States / cities
Birmingham, Alabama • Fresno, California • San Diego, California + 24 more
Source: ClinicalTrials.gov public record
Updated Jun 27, 2024 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

NCT01659866
View directory record Official record
Conditions
Infection
Interventions
Ciprofloxacin, trimethoprim-sulfamethoxazole, cefuroxime, ceftriaxone, gentamicin, amikacin, aztreonam, imipenem
Drug
Lead sponsor
Northwestern University
Other
Eligibility
30 Years to 90 Years · Male only
Enrollment
563 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2016
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jun 24, 2019 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional

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)

NCT01004445
View directory record Official record
Conditions
Pneumonia
Interventions
Amikacin (BAY41-6551), Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
7
States / cities
Birmingham, Alabama • Melbourne, Florida • Albany, New York + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2011 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional Results available

Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria

NCT01315236
View directory record Official record
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
Liposomal amikacin for inhalation (LAI), placebo
Drug
Lead sponsor
Insmed Incorporated
Industry
Eligibility
18 Years to 85 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
18
States / cities
Birmingham, Alabama • Stanford, California • Denver, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2019 · Synced Sep 2, 2026, 5:47 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study

NCT05227937
View directory record Official record
Conditions
Urinary Tract Infections
Interventions
Amikacin
Drug
Lead sponsor
Antonios Likourezos
Other
Eligibility
14 Years to 110 Years · Female only
Enrollment
75 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2026
U.S. locations
1
States / cities
Brooklyn, New York
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 2, 2026, 5:47 PM EDT
Terminated Phase 3 Interventional

Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

NCT03409679
View directory record Official record
Conditions
Pneumonia
Interventions
Murepavadin, Two anti-pseudomonal antibiotics
Drug
Lead sponsor
Polyphor Ltd.
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
3
States / cities
Chicago, Illinois • Springfield, Missouri • Greensboro, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional Results available

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

NCT00775138
View directory record Official record
Conditions
Bronchiectasis
Interventions
280 mg Arikayce™, Matching Placebo for Cohort 1, 560 mg Arikayce™, Matching Placebo for Cohort 2
Drug
Lead sponsor
Insmed Incorporated
Industry
Eligibility
18 Years and older
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
2
States / cities
Washington D.C., District of Columbia • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jul 9, 2019 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Not applicable Interventional

Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF)

NCT00153634
View directory record Official record
Conditions
Cystic Fibrosis, Chronic Bronchitis
Interventions
IV amikacin, PO azithromycin, IV ceftazidime, PO ciprofloxacin, IV meropenem, IV piperacillin-tazobactam, IV ticarcillin-clavulanate, IV tobramycin
Drug
Lead sponsor
Seattle Children's Hospital
Other
Eligibility
14 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2007
U.S. locations
8
States / cities
Iowa City, Iowa • St Louis, Missouri • Cincinnati, Ohio + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 12, 2008 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

NCT00000641
View directory record Official record
Conditions
Mycobacterium Avium-intracellulare Infection, HIV Infections
Interventions
Ciprofloxacin hydrochloride, Ethambutol hydrochloride, Amikacin sulfate, Azithromycin, Rifampin, Clofazimine
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
13 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Ends 1994
U.S. locations
16
States / cities
Torrance, California • Indianapolis, Indiana • St Louis, Missouri + 10 more
Source: ClinicalTrials.gov public record
Updated Nov 2, 2021 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 3 Interventional

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

NCT04677569
View directory record Official record
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
ALIS, Azithromycin, Ethambutol, ELC (matching placebo for ALIS)
Drug
Lead sponsor
Insmed Incorporated
Industry
Eligibility
18 Years and older
Enrollment
425 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
90
States / cities
Birmingham, Alabama • Fresno, California • Los Angeles, California + 71 more
Source: ClinicalTrials.gov public record
Updated Feb 2, 2026 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 3 Interventional Results available

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

NCT01799993
View directory record Official record
Conditions
Pneumonia, Bacterial
Interventions
Amikacin Inhalation Solution (BAY41-6551), Aerosolized Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older
Enrollment
725 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
32
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 27 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2018 · Synced Sep 2, 2026, 5:47 PM EDT
Terminated Phase 3 Interventional

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

NCT06418711
View directory record Official record
Conditions
MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous
Interventions
Clofazimine Inhalation Suspension, Placebo
Drug
Lead sponsor
Mannkind Corporation
Industry
Eligibility
18 Years to 85 Years
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
54
States / cities
Birmingham, Alabama • Fresno, California • Los Angeles, California + 47 more
Source: ClinicalTrials.gov public record
Updated Nov 11, 2025 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional Results available

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

NCT01969799
View directory record Official record
Conditions
Pneumonia, Bacterial
Interventions
Amikacin fosfomycin inhalation solution, Aerosolized placebo
Drug
Lead sponsor
Cardeas Pharma
Industry
Eligibility
18 Years to 80 Years
Enrollment
143 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
16
States / cities
Los Angeles, California • Gainesville, Florida • Jacksonville, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2017 · Synced Sep 2, 2026, 5:47 PM EDT
Terminated Phase 2 Interventional Results available

Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

NCT00707239
View directory record Official record
Conditions
Pneumonia, Bacterial
Interventions
tigecycline, imipenem/cilastatin
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
3
States / cities
Louisville, Kentucky • Omaha, Nebraska • Morgantown, West Virginia
Source: ClinicalTrials.gov public record
Updated Jul 9, 2012 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers

NCT02709265
View directory record Official record
Conditions
Healthy
Interventions
amikacin/fosfomycin
Drug
Lead sponsor
Cardeas Pharma
Industry
Eligibility
18 Years to 80 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 10, 2016 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 3 Interventional

Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection

NCT00035425
View directory record Official record
Conditions
Febrile Neutropenia
Interventions
linezolid, vancomycin
Drug
Lead sponsor
Pfizer
Industry
Eligibility
13 Years and older
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2002
U.S. locations
16
States / cities
Los Angeles, California • Springfield, Illinois • The Bronx, New York + 5 more
Source: ClinicalTrials.gov public record
Updated Nov 30, 2009 · Synced Sep 2, 2026, 5:47 PM EDT
Terminated Early Phase 1 Interventional

Patients Response to Early Switch To Oral:Osteomyelitis Study

NCT02099240
View directory record Official record
Conditions
Osteomyelitis
Interventions
oral antibiotics, intravenous antibiotics
Drug · Procedure
Lead sponsor
Julio Ramirez
Other
Eligibility
18 Years to 100 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Apr 5, 2021 · Synced Sep 2, 2026, 5:47 PM EDT
Completed Phase 2 Interventional

Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

NCT01021436
View directory record Official record
Conditions
Pneumonia
Interventions
Amikacin inhalation solution (BAY41-6551)
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007
U.S. locations
4
States / cities
Birminghan, Alabama • Cincinnati, Ohio • Memphis, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2016 · Synced Sep 2, 2026, 5:47 PM EDT
Terminated Phase 2 Interventional Results available

Clinical Trials to Reduce the Risk of Antimicrobial Resistance

NCT01570192
View directory record Official record
Conditions
Bacterial Pneumonia
Interventions
IV meropenem, I.V. Meropenem, Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h, Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage., tobramycin nebulization
Drug · Device
Lead sponsor
University of Florida
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
8
States / cities
San Mateo, California • Gainesville, Florida • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2017 · Synced Sep 2, 2026, 5:47 PM EDT