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Clavulanic acid

Generic Name
Clavulanic acid
Brand Names
Clavulin, Augmentin
Drug Type
Small Molecule
Chemical Formula
C8H9NO5
CAS Number
58001-44-8
Unique Ingredient Identifier
23521W1S24
Background

Clavulanic acid is a beta-lactamase inhibitor that is frequently combined with Amoxicillin or Ticarcillin to fight antibiotic resistance by preventing their degradation by beta-lactamase enzymes, broadening their spectrum of susceptible bacterial infections. Clavulanic acid is derived from the organism Streptomyces clavuligerus.When it is combined with amoxicillin, clavulanic acid is frequently known as Augmentin, Co-Amoxiclav, or Clavulin.

Indication

Clavulanic acid combined with other antibiotics is indicated to prevent the development of drug-resistant strains of bacteria and promotes their therapeutic antibacterial effects.

The following conditions, when they produced beta-lactamases, have been treated with a combination of amoxicillin and clavulanic acid or ticarcillin and clavulanic acid:

Acute otitis media caused by H. influenzae and M. catarrhalis

Sinusitis due to H. influenzae and M. catarrhalis

Lower respiratory tract infections due to Haemophilus influenzae, S.aureus, Klebsiella species, and Moraxella catarrhalis

Skin and skin structure infections caused by Staphylococcus aureus, Escherichia coli, and Klebsiella species

Urinary Tract Infections due to E. coli, Klebsiella species of bacteria, and Enterobacter species of bacteria, S.marcescens, or S.aureus

Gynecologic infections due to a variety of bacteria, including P.melaninogenicus, Enterobacter species, E.Coli species, Klebsiella species, S. aureus, S.epidermidis

Septicemia due to a variety of bacteria, including Klebsiella species, E.Coli species, S.aureus, or Pseudomonas species

Bone and joint infections due to S.aureus

Intraabdominal infections due to E.Coli, K.pnemoniae, or B.fragilis group

A note on susceptibility

It should be noted that it is only to be administered in infections that are confirmed or highly likely to be caused by susceptible bacteria. Culture and susceptibility tests should be performed if possible and used in selecting whether this antibiotic is prescribed. When beta-lactamase enzyme production is not detected during microbiological testing, clavulanic acid should not be used. When these tests are not available patterns of local infection and susceptibility may be used to determine the appropriateness of using clavulanic acid. Ticarcillin with clavulanate has shown particular efficacy in mixed infections in addition to empiric therapy before determining the susceptibility of causative organisms. The ticarcillin-clavulanic acid combination may prove to be an effective single-agent antibiotic therapy to treat infections where a regimen of several drugs may normally be used.

Associated Conditions
Infection Due to Escherichia Coli, Skin and skin structure infections, Acute Uncomplicated Pyelonephritis, Bronchitis, Haemophilus Influenzae, Lower Respiratory Infection, Otitis Media (OM), Moraxella catarrhalis, Upper Respiratory Tract Infection, Acute Cystitis, Cysto-Urethritis, Bone and Joint Infections, Sinusitis, Intraabdominal Infections, Tonsillitis, Proteus mirabilis, Lower Respiratory Tract Infection (LRTI), Neisseria Gonorrhoeae Infection, Susceptible Bacterial Infections, Pharyngitis, Bacterial infection due to streptococcus, group A, Urinary Tract Infection, Septicemia, Bacterial Infections, Bacterial Pneumonia, Streptococcus Pneumoniae, Gynecological Infection

Prophylactic Antibiotic in Non-complicated Low Risk Lap Cholecystectomy (LC)

Not yet recruiting
Conditions
Cholecystectomy, Laparoscopic
Interventions
First Posted Date
2024-01-05
Last Posted Date
2024-01-05
Lead Sponsor
Assiut University
Target Recruit Count
200
Registration Number
NCT06193837

Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening

Phase 4
Not yet recruiting
Conditions
Tooth Diseases
Tooth Wear
Interventions
Procedure: Surgical crown lengthening
First Posted Date
2023-06-29
Last Posted Date
2023-07-19
Lead Sponsor
Biruni University
Target Recruit Count
28
Registration Number
NCT05925179

LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media

Not Applicable
Completed
Conditions
Upper Respiratory Tract Infections
Interventions
Drug: 0.9% NaCl physiological saline Nasal-spraying
Combination Product: LiveSpo Navax®
First Posted Date
2023-04-07
Last Posted Date
2024-08-22
Lead Sponsor
Anabio R&D
Target Recruit Count
175
Registration Number
NCT05804123
Locations
🇻🇳

Thai Binh University of Medicine and Pharmacy, Thai Binh Medical University Hospital and Thai Binh Children's Hospital, Thai Binh, Vietnam

A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS

Phase 2
Withdrawn
Conditions
Infections, Bacterial
Interventions
First Posted Date
2022-04-22
Last Posted Date
2025-03-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT05340257
Locations
🇧🇷

GSK Investigational Site, São Paulo, Brazil

Collaborative Urological Prosthetics Investigation Directive Research Group

Early Phase 1
Active, not recruiting
Conditions
Erectile Dysfunction
Penile Prosthesis Infection
Interventions
First Posted Date
2021-10-29
Last Posted Date
2025-03-10
Lead Sponsor
University of Chicago
Target Recruit Count
800
Registration Number
NCT05100654
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India

Phase 4
Completed
Conditions
Otitis Media
Infections, Respiratory Tract
Respiratory Tract Infections
Interventions
First Posted Date
2020-10-23
Last Posted Date
2024-06-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
310
Registration Number
NCT04600752
Locations
🇮🇳

GSK Investigational Site, Purne, India

Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid

Phase 1
Completed
Conditions
Cocaine Dependence
Interventions
Other: Placebo
First Posted Date
2020-06-02
Last Posted Date
2023-06-22
Lead Sponsor
Temple University
Target Recruit Count
13
Registration Number
NCT04411914
Locations
🇺🇸

Temple University Episcopal Hospital, Philadelphia, Pennsylvania, United States

Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid

Phase 1
Completed
Conditions
Cocaine Dependence, in Remission
Cocaine-Related Disorders
Cocaine Abuse, in Remission
Interventions
First Posted Date
2019-06-14
Last Posted Date
2020-10-26
Lead Sponsor
Temple University
Target Recruit Count
9
Registration Number
NCT03986762
Locations
🇺🇸

Episcopal Hospital Medical Arts Building, Philadelphia, Pennsylvania, United States

An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction

Phase 2
Recruiting
Conditions
Tobacco Use Disorder
Interventions
Drug: Placebo oral capsule
First Posted Date
2018-10-19
Last Posted Date
2023-11-30
Lead Sponsor
University of Missouri-Columbia
Target Recruit Count
30
Registration Number
NCT03713424
Locations
🇺🇸

University of Missouri - Columbia, Columbia, Missouri, United States

Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
Drug: Clavamox
First Posted Date
2018-10-11
Last Posted Date
2019-05-14
Lead Sponsor
Pharmtechnology LLC
Target Recruit Count
56
Registration Number
NCT03702894
Locations
🇷🇺

State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2", Yaroslavl, Yaroslavl Region, Russian Federation

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