AUGMENTIN™ in Dental Infections
Condition: Focal Infection, Dental
MeSH terms: Infections; Communicable Diseases; Focal Infection, Dental; Focal Infection
Intervention: Amoxicillin/clavulanate; Clindamycin
Intervention description: Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.; Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.
Intervention MeSH terms: Amoxicillin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Odontogenic (Dental) Infections; Dental infections, periapical abscess; Bacterial infection

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.
    

Eligibility 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