TELI COM - Telithromycin in Children With Otitis Media

Inclusion Criteria: Subjects meeting all of the following criteria will be considered for enrollment into the study: * Subjects ≥6 months and \<72 months (\< 6 years) of age; * Recent (within the last 72 hours) and rapid onset of AOM symptoms and signs; * The presence of MEF on otoscopy indicated by a bulging tympanic membrane; * Otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep; * At least 1 of the following clinical findings not specific to AOM: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability; * Caregiver-reported AOM symptoms sufficient for entry according to protocol criteria. * Caregiver-reported AOM symptoms diary * Tympanometry exhibiting: * Type B curve or positive pressure peak curves. Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: * Uncertain diagnosis of AOM or mild to moderate symptoms and signs of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days. * Otorrhea or tympanostomy tube present in the ear to be evaluated; * Otitis externa; * Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with \<25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection; * Known congenital long QT syndrome; * Known or suspected uncorrected hypokalemia (≤3 mmol/L \[mEq/L\]), hypomagnesemia, bradycardia (\<50 bpm); * Myasthenia gravis; * Known impaired renal function, as shown by creatinine clearance ≤25 mL/min; * History of hypersensitivity or intolerance to macrolides or azithromycin; * Previous enrollment in this study or previous treatment with telithromycin; * Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.