amoxicillin-clavulanate: Clinical Trials

21 trials of amoxicillin-clavulanate, newest first

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10 completed, 6 recruiting, 2 not yet recruiting, 2 unknown. 7 Phase 3, 7 Phase 4, 2 Not applicable, 2 Phase 1, 2 Phase 2.

By phase and status

PhaseTrialsStatus
Phase 37Completed 5, Not yet recruiting 1, Recruiting 1
Phase 47Completed 2, Recruiting 2, Unknown 2, Withdrawn 1
Not applicable2Completed 1, Recruiting 1
Phase 12Completed 1, Recruiting 1
Phase 22Completed 1, Not yet recruiting 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Shared decision-making, amoxicillin-clavulanate, Appendectomy - Acute Appendicitis
Phase 2Not yet recruitingAssistance Publique - Hôpitaux de Paris5602026-10-012026-10-05
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
Amoxicillin, Amoxicillin-Clavulanate, Amoxicillin Placebo - Acute Otitis Media (AOM)
Phase 4RecruitingNader Shaikh11002026-10-012026-10-20
Non-antibiotic Management in Acute Uncomplicated Diverticulitis
Symptomatic treatment (ibuprofen and acetaminophen), Amoxicillin-clavulanate, Ciprofloxacin plus metronidazole - Acute Uncomplicated Diverticulitis
Phase 4WithdrawnMontefiore Medical Center2026-07-012026-08-31
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.
amoxicillin-clavulanate, Amoxicillin-clavulanate ciprofloxacin - C15.378
Phase 3Not yet recruitingVersailles Hospital15262026-03-012026-03-19
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil - Healthy Volunteer, Pharmacokinetics
Phase 1RecruitingBasilea Pharmaceutica962025-01-072026-07-09
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Ampicillin for Injection, Ceftriaxone for Injection, Amoxicillin - Community Acquired Pneumonia in Children
Phase 4RecruitingMedical College of Wisconsin2362024-08-222026-03-02
Effect of Tebipenem on Normal Human Intestinal Microbiota
TBPM-PI-HBr, amoxicillin-clavulanate - Healthy Volunteers
Phase 1CompletedSpero Therapeutics302020-02-102021-05-04
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
OP0201, Placebo, Amoxicillin-clavulanate - Acute Otitis Media
Phase 2CompletedNovus Therapeutics, Inc1032019-02-212020-08-18
Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
Sulopenem, Sulopenem-Etzadroxil/Probenecid, Ertapenem - Complicated Urinary Tract Infections
Phase 3CompletedIterum Therapeutics, International Limited13952018-09-182020-12-29
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
Ertapenem, Sulopenem-Etzadroxil/Probenecid, Ciprofloxacin - Intra Abdominal Infections
Phase 3CompletedIterum Therapeutics, International Limited6742018-09-182020-12-01
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
anti-tuberculosis drug - Tuberculosis
RecruitingBeijing Children's Hospital8002018-07-012018-08-15
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
Amoxicillin, Amoxicillin-clavulanate, Cefdinir - Pneumonia
Phase 4CompletedNational Institute of Allergy and Infectious Diseases (NIAID)3852016-12-022021-02-03
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem - Pharmacokinetics, Amoxicillin-clavulanate
Not applicableRecruitingUniversity Hospital, Ghent3002016-08-192026-09-21
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Ceftriaxone, Moxifloxacin or Levofloxacin, Piperacillin-tazobactam - Community-acquired Pneumonia, Influenza, COVID-19
Phase 3RecruitingUMC Utrecht200002016-04-112024-07-12
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Amoxicillin-clavulanate, Placebo - Sinusitis, Respiratory Tract Infections
Phase 3CompletedNader Shaikh5152016-02-012023-06-29
Diverticulitis: Antibiotics or Close Observation?
Amoxicillin-clavulanate - Diverticulitis
Phase 4UnknownAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)5332010-05-012012-10-29
Acute Otitis Media (AOM) Therapy Trial in Young Children
amoxicillin-clavulanate, Placebo - Acute Otitis Media
Phase 4CompletedUniversity of Pittsburgh2912006-11-012016-12-05
Amoxicillin Clavulanate in Treatment of Acute Otitis Media
amoxicillin-clavulanate, Placebo - Acute Otitis Media
Phase 4UnknownUniversity of Turku3202006-03-012009-02-11
Do Antibiotics Prevent Anal Fistulae Formation?
Amoxicillin-Clavulanate, Placebo - Anal Fistula
Not applicableCompletedAnkara University1512005-09-012009-11-16
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Clarithromycin, Amoxicillin - Acute Bacterial Sinusitis (ABS)
Phase 3CompletedAbbott4372003-05-012008-03-27

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Conditions studied

Otitis Media (4)  ·  Community-Acquired Pneumonia (2)  ·  Pneumonia (2)  ·  Respiratory Tract Infections (2)  ·  Abscess (1)  ·  Acute Disease (1)  ·  Appendicitis (1)  ·  COVID-19 (1)  ·  Diverticulitis (1)  ·  Diverticulitis, Colonic (1)  ·  Febrile Neutropenia (1)  ·  Influenza, Human (1)  ·  Intraabdominal Infections (1)  ·  Lung Diseases (1)  ·  Lymphoma, Follicular (1)

Sponsors

Iterum Therapeutics, International Limited (2)  ·  Nader Shaikh (2)  ·  Abbott (1)  ·  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1)  ·  Ankara University (1)  ·  Assistance Publique - Hôpitaux de Paris (1)  ·  Basilea Pharmaceutica (1)  ·  Beijing Children's Hospital (1)  ·  Medical College of Wisconsin (1)  ·  Montefiore Medical Center (1)  ·  National Institute of Allergy and Infectious Diseases (NIAID) (1)  ·  Novus Therapeutics, Inc (1)  ·  Spero Therapeutics (1)  ·  UMC Utrecht (1)  ·  University Hospital, Ghent (1)

Countries

United States (11)  ·  Hungary (4)  ·  Estonia (3)  ·  Finland (3)  ·  France (3)  ·  Belgium (2)  ·  Canada (2)  ·  Georgia (2)  ·  Italy (2)  ·  Latvia (2)  ·  Netherlands (2)  ·  Poland (2)  ·  Romania (2)  ·  Spain (2)  ·  Australia (1)

Top investigators

A-Dong Shen, Master (1)  ·  Aino Ruohola, MD, PhD (1)  ·  Alejandro Hoberman, MD (1)  ·  Annick de Jaeger, MD (1)  ·  Colin McArthur, Dr (1)  ·  Derek Angus, Prof (1)  ·  Ellen R Wald, MD (1)  ·  James Taylor, MD (1)  ·  John Marshall, Prof (1)  ·  Kamal Hamed, MD (1)  ·  Lennie Derde, MD (1)  ·  Marc Bonten, Prof (1)  ·  Marie A Boermeester, MD, PhD, MSc (1)  ·  Matti Uhari, Professor (1)

Results publications

PMID 42572144, PMID 16091913, PMID 20368317, PMID 21098526, PMID 21226576, PMID 21226577, PMID 24797294, PMID 26183005, PMID 26651157, PMID 27686365, PMID 28340091, PMID 30572868, PMID 32267771, PMID 32876697, PMID 33394942, PMID 33509275, PMID 33631065, PMID 34251506, PMID 34351721, PMID 34351722, PMID 34473343, PMID 34606578, PMID 34851411, PMID 35040920, PMID 35315874, PMID 35323040, PMID 36068705, PMID 36942550, PMID 36967714, PMID 37039790, PMID 37171965, PMID 37489818, PMID 37490085, PMID 37877585, PMID 37888913, PMID 38432233, PMID 40261382, PMID 40360262, PMID 42823695, PMID 6468199, PMID 9823799

NIH funding

2025 (3), 2009 (1), 2015 (1), 2023 (1), U01AI066007 (1), U01AI118506 (1)