Drugs / Amoxicillin-clavulanate
last change Sep 2026 re-read 3 minutes ago

Amoxicillin-clavulanate

Other / unclassified

Developed for
otitis media · pneumonia · appendicitis · bronchitis · neutropenia · pulmonary tuberculosis · skin disease caused by bacterial infection · small intestinal bacterial overgrowth
+6 more · suppurative otitis media · thyroid tumor · tuberculosis · anal fistula · diverticulitis of colon · urinary tract infection
Investigated by
Alejandro Hoberman · Alesund Hospital · Antonio Barone · Australian and New Zealand Intensive Care Research Centre · Berry Consultants · Centre Of Research Excellence in Tuberculosis Control
+46 more · Chang Gung Memorial Hospital · Department for International Development, United Kingdom · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Finnish Institute for Health and Welfare · George Washington University · Global Coalition for Adaptive Research · Haukeland University Hospital · Helse Stavanger HF · Hospital de Granollers · Intensive Care National Audit & Research Centre · International Centre for Diarrhoeal Disease Research, Bangladesh · Kenya Ministry of Health · London School of Hygiene and Tropical Medicine · Medical College of Wisconsin · Medical Research Council · Medical Research Institute of New Zealand · Nat Intensive Care Surveillance - MORU · National Institute for Health Research, United Kingdom · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute on Deafness and Other Communication Disorders (NIDCD) · National Institutes of Health (NIH) · National University Hospital, Singapore · Oslo University Hospital · Queen Mary Hospital, Hong Kong · St. Marianna University School of Medicine · TASK Applied Science · The Baruch Padeh Medical Center, Poriya · The University of Hong Kong · Trondheim University Hospital · UMC Utrecht · Unity Health · University Hospital of North Norway · University Hospital, Akershus · University of Nairobi · University of Oulu · University of Oxford · University of Pittsburgh · University of Pittsburgh Medical Center · University of Turku · University of Virginia · Versailles Hospital · Virginia Commonwealth University · Wake Forest University Health Sciences · Wellcome Trust · Western Sydney Local Health District · Wyeth is now a wholly owned subsidiary of Pfizer

Trials 19

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT07451171 Apr → Aug 2026 overdue small intestinal bacterial overgrowth University of Virginia Recruiting No outcome recorded
Phase 2 NCT05664568 Mar 2023 → Jul 2024 pulmonary tuberculosis Western Sydney Local Health District Unknown No outcome recorded
Phase 2 NCT04629378 Aug 2020 → Jun 2021 tuberculosis TASK Applied Science Completed No outcome recorded
Phase 35 trials · 1 met primary
Phase 3 NCT07483736 Mar 2026 → Mar 2028 expected — Versailles Hospital Not yet recruiting No outcome recorded
Phase 3 NCT05508152 Feb 2021 → Jan 2023 — Hospital de Granollers Completed No outcome recorded
Phase 3 NCT04041791 Aug 2019 → Apr 2024 pneumonia University of Oxford Completed No outcome recorded
Phase 3 NCT02735707 Apr 2016 → Feb 2026 overdue pneumonia UMC Utrecht Recruiting Mixed
Phase 3 NCT01244581 Sep 1999 → Jun 2012 suppurative otitis media University of Oulu Completed Met primary
Phase 47 trials · 1 met primary
Phase 4 NCT06494072 Aug 2024 → May 2028 expected — Medical College of Wisconsin Recruiting No outcome recorded
Phase 4 NCT06020716 Aug 2023 → Apr 2028 expected bronchitis Helse Stavanger HF Recruiting No outcome recorded
Phase 4 NCT05393505 Oct 2022 → Mar 2025 neutropenia The University of Hong Kong Unknown No outcome recorded
Phase 4 NCT04082598 Oct 2016 → Sep 2018 — Antonio Barone Completed No outcome recorded
Phase 4 NCT00377260 Nov 2006 → Apr 2009 otitis media University of Pittsburgh Completed Mixed
Phase 4 NCT00368537 Sep 2006 → Sep 2008 skin disease caused by bacterial infection Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 4 NCT00299455 Mar 2006 → Dec 2008 otitis media University of Turku Unknown Met primary
Phase not applicable4 trials · 1 missed
— NCT04268407 Feb 2020 → Dec 2021 thyroid tumor Chang Gung Memorial Hospital Completed No outcome recorded
— NCT02740647 Apr 2016 → Feb 2017 — The Baruch Padeh Medical Center, Poriya Unknown No outcome recorded
— NCT02567825 Nov 2015 → Mar 2020 otitis media Alejandro Hoberman Completed Missed primary
— NCT02724410 Jan 2011 → Nov 2013 appendicitis Wake Forest University Health Sciences Completed Mixed
Comparator or background therapy19 trials
Phase 0 NCT04414722 Background Jan 2021 → May 2023 diarrheal disease Georgetown University Completed No outcome recorded
Phase 2 NCT03818815 Comparator Feb 2019 → Mar 2020 otitis media Novus Therapeutics, Inc Completed Missed primary
Phase 2 NCT02365623 Background Feb 2015 → Nov 2018 multidrug-resistant tuberculosis Janssen Pharmaceutical K.K. Completed No outcome recorded
Phase 2 NCT01511107 Comparator Jan 2012 → Sep 2015 otitis media Alejandro Hoberman Terminated No outcome recorded
Phase 2/3 NCT01530763 Background Sep 2012 → Apr 2014 infectious disease Forest Laboratories Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2002-10-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Provides Updated Outlook on 4th Quarter 2002 Earnings in Light of Amox/Clav ANDA Approval tevapharm.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 39 sources stand behind the page.

FieldValueCited text
Known as Amoxicillin-clavulanate “Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after...” NCT02365623 ↗
37

“Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.” NCT00368537 ↗

“Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.” NCT06443502 ↗

“PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h” NCT01669980 ↗

“Amoxicillin-clavulanate 875mg tid PO” NCT04512638 ↗

NCT02735707 ↗

NCT03357614 ↗

NCT02567825 ↗

NCT03818815 ↗

NCT04268407 ↗

NCT04041791 ↗

Show 27 more sources

Known as amox/clav “In the first trial, we compared the efficacy of amoxicillin/clavulanate (amox/clav) administered for 10 days vs. that of placebo” PMID 37171965 ↗ Apr 2023
Known as amoxicillin-clavulanate potassium “Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.” NCT00377260 ↗
Known as Augmentin “Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with...” NCT00299455 ↗
Known as Augmentin ES-600 “Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.” NCT00377260 ↗
Action Inhibit “potassium clavulanate, a beta-lactamase inhibitor” NCT02891915 ↗
Modality Other / unclassified “oral beta-lactam antibiotic therapy (amoxicillin, amoxicillin-clavulanate, cefdinir)” NCT02891915 ↗
Route Intravenous “Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.” NCT00368537 ↗