Acute Otitis Media (AOM) Therapy Trial in Young Children
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: amoxicillin-clavulanate; Placebo
Intervention description: Augmentin ES-600™: Amoxicillin-clavulanate potassium (600/42.9 mg per 5 mL), administered at a dose of 90/6.4 mg/kg/day in 2 divided doses for 10 days with strawberry cream flavor.; Same base formulation of the licensed product Augmentin ES-600™, with the same strawberry cream flavor.
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 291.0
Sex: All
Minimum age: 6 Months
Maximum age: 23 Months
Healthy volunteers: No
Keywords: acute otitis media, infants, children

Summary:

      The purpose of this study is to learn whether or not all children with ear infections (acute
      otitis media or AOM) should be treated with antibiotics. The study will compare two treatment
      strategies, "watchful waiting" or treatment with antibiotics, to determine which is more
      appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23
      months, with AOM will be enrolled in the study. They will be treated either with Augmentin
      (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will
      be asked to write information about their child in a Patient Diary. A general physical exam,
      including an ear exam, will be performed 4 times during the study. A mucus sample will be
      collected from the back of each child's nose. Parents will be asked questions during phone
      calls and at every visit. If a child has not improved or has worsened, the investigators will
      prescribe a different antibiotic that is known to kill resistant germs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  aged 6 to 23 months

          -  have received at least two doses of pneumococcal conjugate vaccine (Prevnar) and
             Haemophilus influenzae type B vaccine

          -  have evidence of acute otitis media (AOM) defined as:

               1. Recent (within 48 hours), onset of signs and symptoms and a score of greater than
                  or equal to 3 on the AOM-SOS scale.

               2. Middle ear effusion evidenced by at least two of the following:

          -  decreased or absent tympanic membrane mobility by pneumatic otoscopy,

          -  yellow or white discoloration of the tympanic membrane,

          -  opacification of the tympanic membrane, plus

          -  1+ bulging of the tympanic membrane with either marked erythema or otalgia, or

          -  2+ or 3+ bulging of the tympanic membrane

        Exclusion Criteria:

          -  certain signs or symptoms (e.g., toxic appearance [capillary refill greater than 3
             seconds, systolic blood pressure less than 60 mm Hg], otalgia for a period greater
             than 48 hours, spontaneous perforation of the tympanic membrane and drainage or
             temperature greater than or equal to 105 degrees F);

          -  clinical or anatomical characteristics that might obscure response to treatment (e.g.,
             tympanostomy tube[s] in place or a history of tympanostomy tubes, unrepaired or
             repaired overt or submucous cleft palate, high-arched palate, or Down's syndrome);

          -  underlying systemic problems that might obscure response to infection (e.g., serious
             underlying disease [e.g., cystic fibrosis, neoplasm, juvenile diabetes]), concomitant
             infection that would preclude evaluation of the response of the child's AOM to study
             medication, known renal insufficiency (i.e., serum creatinine greater than or equal to
             1.5 times upper limit of normal for age), known hepatic insufficiency or a history of
             amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction,
             history of immune dysfunction, deficiency or receipt of immunosuppressive therapy,
             chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease),
             malignancy;

          -  sensorineural hearing loss either unilateral or bilateral;

          -  comedications (e.g., systemic corticosteroids at any point while enrolled in the
             study, more than one dose of systemic antimicrobial therapy within 96, any
             investigational drug or vaccine;

          -  hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or
             phenylketonuria or known hypersensitivity to aspartame;

          -  unable to complete the study protocol or not having access to a telephone; and

          -  current enrollment in another study or previously enrolled in this study.