AUGMENTIN™ in Dental Infections

• Status: Completed
• Trial end date: 2013-12-28
• Target enrollment: 0
• Participant gender: All

Summary

In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of odontogenic infection. Therefore, this study is designed to generate data to support its use by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects with acute odontogenic infections with or without abscess. This will be a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess. The study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infections. A total of 472 subjects will be randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show treatment response on Day 5, assessments will be performed on Day 7.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Criteria

Inclusion Criteria:

• Inclusion Criterion:

• Adult (≥18 years of age) males and females

• Subjects with diagnosis of acute odontogenic infections of following types requiring antibiotic therapy

• Periapical abscess

• Aute periodontitis

• Pericoronitis • Provision of voluntary written informed consent

Exclusion Criteria:

• Subjects presenting with complications like osteomyelitis, dentocutaneous fistula, dentoalveolar fistula, draining sinus, facial-space swelling, necrotizing fasciitis OR subjects requiring hospitalization, aggressive intravenous antimicrobial therapy, requiring local application of antimicrobials for the treatment of odontogenic infection.

• Subjects presenting with odontogenic infections secondary to traumatic injury to the face.

• Subjects with valvular heart disease, prosthetic heart valves, congenital heart disease or any other conditions prone to infective endocarditis

• Subjects with a known clinically significant abnormality identified at screening on physical examination or known laboratory tests which, in the judgment of the Investigator, would preclude safe completion of the study

• Subject who has taken a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration

• Immunocompromised subjects or subjects on immunosuppressants or systemic corticosteroids

• Subjects with chronic gingivitis or chronic periodontitis

• Subjects with uncontrolled diabetes mellitus or HIV infection

• History of hypersensitivity or allergic reactions to any beta-lactam such as penicillin, cephalosporin, moxicillin/clavulanic acid or clindamycin

• Concomitant infection, that requires additional antimicrobial therapy during the study period

• Subjects with clinically significant liver disease as defined by alanine aminotransferase (ALT) or aspartate minotransferase (AST) levels >2.5 times the upper limit of normal (ULN) or a diagnosis of chronic active hepatitis including that of viral etiology, or on antiviral or immunosuppressive therapy.

• Subjects with renal impairment with serum creatinine > 1.7 mg/dl in men and >1.5mg/dl in women.

• Subjects with infectious mononucleosis

• Subjects with history of documented Clostridium difficile-associated diarrhoea or existing diarrhoea

• Concomitant treatment with oral anticoagulants, methotrexate or probenicid

• Female subjects of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable method of contraception

• Subjects with lactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption

• Pregnant or lactating female subjects