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ampicillin/clavulanate
Ampicillin inhibits bacterial cell wall synthesis while clavulanate protects ampicillin from degradation by bacterial beta-lactamases.
Ampicillin inhibits bacterial cell wall synthesis while clavulanate protects ampicillin from degradation by bacterial beta-lactamases. Used for Bacterial infections caused by beta-lactamase-producing organisms susceptible to ampicillin/clavulanate, Otitis media, Sinusitis.
At a glance
| Generic name | ampicillin/clavulanate |
|---|---|
| Also known as | Augmentin |
| Sponsor | Phoenix Children's Hospital |
| Drug class | Beta-lactam antibiotic with beta-lactamase inhibitor |
| Target | Penicillin-binding proteins (PBPs); bacterial beta-lactamases |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Ampicillin is a beta-lactam antibiotic that binds to penicillin-binding proteins and disrupts peptidoglycan cross-linking in the bacterial cell wall, leading to cell lysis and death. Clavulanate is a beta-lactamase inhibitor that irreversibly binds to and inactivates bacterial beta-lactamases, preventing them from destroying ampicillin and thereby extending ampicillin's spectrum of activity against beta-lactamase-producing organisms.
Approved indications
- Bacterial infections caused by beta-lactamase-producing organisms susceptible to ampicillin/clavulanate
- Otitis media
- Sinusitis
- Respiratory tract infections
- Urinary tract infections
- Skin and soft tissue infections
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Rash
- Abdominal pain
- Allergic reaction
Key clinical trials
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (PHASE4)
- 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. (PHASE3)
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
- Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis (PHASE4)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- Collaborative Urological Prosthetics Investigation Directive Research Group (EARLY_PHASE1)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ampicillin/clavulanate CI brief — competitive landscape report
- ampicillin/clavulanate updates RSS · CI watch RSS
- Phoenix Children's Hospital portfolio CI