A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Inclusion Criteria:

• Clinical diagnosis, documented by medical history and physical examination, is AOM I 1week.

• Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may beexpressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may bebased on reports from parents or legally authorized representatives; Discharge fromthe external auditory canal (following acute perforation of the tympanic membrane).

• At least two (2) of the following signs are present in at least one ear: Full orbulging or perforated tympanic membrane, which may be erythematous (note - sincehyperemia may be present in a febrile or crying child, a red tympanic membrane aloneis insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasicpneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membraneand edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated byacoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.

• Generally in good health based on medical history, vital signs, physical exam, andhistorical laboratory results.

• Subject must be a suitable candidate for oral antibiotic therapy.

Exclusion Criteria:

• Previous enrollment in this study.

• Enrollment in any other investigational study using unapproved products or unapproveddoses; in the previous four weeks prior to study start.

• Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, othermacrolide and azalide antibiotics, and/or sensitivity to multiple allergens.

• Presence of tympanostorny tubes or otitis externa at Evaluation 1.

• Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1or during the study.

• Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin Gbenzathine) within 4 weeks prior to study drug administration.

• Concomitant infection that requires additional antimicrobial therapy.

• Evidence of chronic, suppurative otitis media.

• Evidence of perforation of the tympanic membrane > 24 hours.

• Evidence of a physiologic, anatomic, or immunologic defect, which would interfere withresolution of this episode of acute otitis media.

• Immunocompromised subject (e.g., neutropenic subjects).

• Presence of a disease, complicating factor (e.g., mastoiditis), or structuralabnormality that would preclude evaluation of the subject's therapeutic response.

• Any expectation that treatment with probenecid will be expected during the study drugadministration period.

• Known significant renal or hepatic impairment.