Active Ingredient History
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Clavulanic acid is used in conjunction with amoxicillin for the treatment of bronchitis and urinary tract, skin, and soft tissue infections caused by beta-lactamase producing organisms. Clavulanic acid competitively and irreversibly inhibits a wide variety of beta-lactamases, commonly found in microorganisms resistant to penicillins and cephalosporins. Binding and irreversibly inhibiting the beta-lactamase results in a restauration of the antimicrobial activity of beta-lactam antibiotics against lactamase-secreting-resistant bacteria. By inactivating beta-lactamase (the bacterial resistance protein), the accompanying penicillin/cephalosporin drugs may be made more potent as well. NCATS
Combination drugs
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Skin Diseases, Bacterial (approved 1996)
Abdomen, Acute (Phase 3)
Abdominal Abscess (Phase 3)
Abdominal Pain (Phase 4)
Abscess (Phase 3)
Acne Vulgaris (Phase 3)
Amoxicillin (Phase 4)
Amputation (Phase 4)
Antibiotic Prophylaxis (Phase 3)
Anticoagulants (Phase 4)
Appendicitis (Phase 4)
Arrhythmias, Cardiac (Phase 3)
Asthma (Phase 2)
Atrial Fibrillation (Phase 4)
Atrial Flutter (Phase 4)
Back Pain (Phase 4)
Bacterial Infections (Phase 4)
Bites and Stings (Phase 2/Phase 3)
Brain Neoplasms (Phase 3)
Bronchitis (Phase 4)
Bronchitis, Chronic (Phase 4)
Cholecystitis, Acute (Phase 4)
Cocaine-Related Disorders (Phase 1)
Communicable Diseases (Phase 4)
Community-Acquired Infections (Phase 4)
COVID-19 (Phase 3)
Cross Infection (Phase 3)
Cystectomy (Phase 3)
Cystic Fibrosis (Phase 4)
Delivery, Obstetric (Phase 4)
Dental Pulp (Phase 4)
Depression (Phase 2)
Depressive Disorder, Major (Phase 2)
Diabetes Mellitus (Phase 3)
Diabetic Foot (Phase 4)
Diarrhea (Phase 4)
Diverticulitis (Phase 4)
Drug-Related Side Effects and Adverse Reactions (Early Phase 1)
Duodenal Ulcer (Phase 3)
Embolism (Phase 4)
Endocarditis (Phase 4)
Enterobacteriaceae Infections (Phase 3)
Erectile Dysfunction (Phase 2)
Febrile Neutropenia (Phase 3)
Fever (Phase 4)
Focal Infection, Dental (Phase 4)
General Surgery (Phase 3)
Head and Neck Neoplasms (Phase 2/Phase 3)
Healthy Volunteers (Phase 1)
Helicobacter pylori (Phase 4)
Hemodialysis, Home (Phase 3)
Hemorrhage (Phase 4)
Hypothermia (Phase 3)
Ileus (Phase 3)
Infections (Phase 4)
Intestinal Diseases (Phase 3)
Intestinal Neoplasms (Phase 3)
Intestinal Perforation (Phase 3)
Intraabdominal Infections (Phase 3)
Jaw Fractures (Phase 1)
Kidney Diseases (Phase 3)
Lymphoma (Phase 3)
Mandibular Diseases (Phase 4)
Neonatal Sepsis (Phase 4)
Neoplasms (Phase 3)
Neutropenia (Phase 3)
Obesity (Phase 1/Phase 2)
Osteomyelitis (Early Phase 1)
Otitis Media ()
Otitis Media, Suppurative (Phase 3)
Out-of-Hospital Cardiac Arrest (Phase 4)
Pain (Phase 4)
Pelvic Infection (Phase 2)
Periodontitis (Phase 2/Phase 3)
Peritonitis (Phase 3)
Pneumonia (Phase 4)
Pneumonia, Aspiration (Phase 4)
Pneumonia, Bacterial (Phase 3)
Pneumonia, Ventilator-Associated (Phase 4)
Postoperative Complications (Phase 4)
Primary Prevention (Phase 4)
Prostatic Neoplasms (Phase 4)
Pulmonary Disease, Chronic Obstructive (Phase 4)
Pulmonary Embolism (Phase 4)
Pyelonephritis (Phase 3)
Rectal Fistula (Phase 3)
Renal Insufficiency, Chronic (Phase 3)
Respiratory Aspiration (Phase 4)
Respiratory Tract Infections (Phase 4)
Rupture (Phase 3)
Salivary Ducts (Phase 4)
Sepsis (Phase 1)
Sinusitis (Phase 4)
Skin Diseases, Infectious (Phase 4)
Sleep Apnea, Obstructive (Phase 4)
Snake Bites (Phase 4)
Soft Tissue Infections (Phase 4)
Squamous Cell Carcinoma of Head and Neck (Phase 3)
Stroke (Phase 4)
Surgery, Oral (Phase 3)
Surgical Wound Infection (Phase 4)
Temporomandibular Joint Disorders (Phase 4)
Therapeutic Equivalency (Phase 1)
Tobacco Use Disorder (Phase 2)
Tonsillectomy (Phase 1/Phase 2)
Tooth Extraction (Phase 4)
Tuberculosis (Phase 2)
Tuberculosis, Pulmonary (Phase 2)
Ulcer (Phase 3)
Urinary Bladder, Neurogenic (Phase 4)
Urinary Bladder, Overactive (Phase 4)
Urinary Tract Infections (Phase 4)
Venous Thrombosis (Phase 4)
Vesico-Ureteral Reflux (Phase 3)
Wound Infection (Phase 4)
Wounds and Injuries (Phase 2/Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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