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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

Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
Drug: Clavamox
First Posted Date
2018-08-06
Last Posted Date
2018-10-15
Lead Sponsor
Pharmtechnology LLC
Target Recruit Count
56
Registration Number
NCT03616301
Locations
🇷🇺

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

Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Not Applicable
Completed
Conditions
Sinusitis
Interventions
Drug: 6 day Prednisone
Drug: 21 day Prednisone
First Posted Date
2016-10-07
Last Posted Date
2020-12-29
Lead Sponsor
Loma Linda University
Target Recruit Count
24
Registration Number
NCT02927834
Locations
🇺🇸

Loma Linda University Medical Center, Loma Linda, California, United States

Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

Phase 4
Active, not recruiting
Conditions
Appendicitis
Interventions
Procedure: Appendectomy
First Posted Date
2016-07-29
Last Posted Date
2023-10-23
Lead Sponsor
Ramon Gorter
Target Recruit Count
302
Registration Number
NCT02848820
Locations
🇳🇱

Medical Center Alkmaar, Alkmaar, Netherlands

🇳🇱

Zuyderland, Heerlen, Netherlands

🇳🇱

AMC, Amsterdam, Netherlands

and more 12 locations

Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

Phase 1
Completed
Conditions
Cocaine Dependence
Cocaine Addiction
Cocaine Abuse
Cocaine-Related Disorders
Interventions
First Posted Date
2015-09-30
Last Posted Date
2023-11-03
Lead Sponsor
Temple University
Target Recruit Count
10
Registration Number
NCT02563769
Locations
🇺🇸

Temple University Hospital - Episcopal Campus, Philadelphia, Pennsylvania, United States

Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-05-01
Last Posted Date
2016-08-30
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
17
Registration Number
NCT02431832
Locations
🇰🇷

Seoul National University Bundang Hospital, Seoul, Korea, Republic of

A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-05-21
Last Posted Date
2014-12-23
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
32
Registration Number
NCT02143323
Locations
🇰🇷

Jieon Lee, Seoul, Korea, Republic of

🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Short Duration Treatment of Non-severe Community Acquired Pneumonia

Phase 2
Conditions
Community Acquired Pneumonia
Interventions
Radiation: Chest X-ray
Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Drug: Placebo (for Augmentin)
Drug: Beta-Lactams
First Posted Date
2013-10-16
Last Posted Date
2017-08-14
Lead Sponsor
Versailles Hospital
Target Recruit Count
310
Registration Number
NCT01963442
Locations
🇫🇷

Foch Hospital, Suresnes, France

🇫🇷

CH Versailles, Le Chesnay, France

🇫🇷

CHI Creteil, Creteil, France

and more 17 locations

Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis

Phase 4
Completed
Conditions
Sinusitis
Interventions
First Posted Date
2013-04-05
Last Posted Date
2017-04-04
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
40
Registration Number
NCT01825408
Locations
🇺🇸

Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals, Chapel Hill, North Carolina, United States

Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage

Not Applicable
Withdrawn
Conditions
Peritonsillar Abscess
Interventions
Drug: Randomization to Placebo
First Posted Date
2012-10-29
Last Posted Date
2017-11-06
Lead Sponsor
Lawson Health Research Institute
Registration Number
NCT01715610
Locations
🇨🇦

London Health Sciences Center, St. Joseph's Hospital, London, Ontario, Canada

Safety and Efficacy of RX-10100 to Treat Major Depressive Disorder

Phase 2
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2011-01-10
Last Posted Date
2013-11-19
Lead Sponsor
Rexahn Pharmaceuticals, Inc.
Target Recruit Count
314
Registration Number
NCT01273376
Locations
🇺🇸

Rexahn Investigative Site, Bellevue, Washington, United States

🇺🇸

Rexahn Investigative Site (2), Bellevue, Washington, United States

🇺🇸

Rexahn Investigative Sites, Lake Jackson, Texas, United States

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