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.