Acute Otitis Media (AOM) Therapy Trial in Young Children

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:
• Recent (within 48 hours), onset of signs and symptoms and a score of greater than or equal to 3 on the AOM-SOS scale.
• 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.