A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Inclusion Criteria:

• Clinical diagnosis, documented by medical history and physical examination, is acuteotitis media <=1 week

• Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness,decreased hearing, or discharge from the external auditory canal (following acuteperforation of the tympanic membrane).

• At least two of the following conditions are present in at least one ear: bulgingtympanic membrane, which may have redness; loss of the normal light reflex andtympanic membrane landmarks and abnormal tympanic membrane mobility on biphasicpneumatic otoscopy, due to the presence of pus or fluid behind it and edema of thetympanic membrane.

• Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.

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

Exclusion Criteria:

• Previous enrollment in this study.

• Enrollment in any other investigational study using unapproved products or unapproveddoses, including investigational vaccines in the previous four weeks prior to studystart.

• Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, otherdrugs, and/or sensitivity to multiple allergens.

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

• Systemic treatment with any anti-infective agent within 7 days (14 days forazithromycin) prior to Evaluation 1 or 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 a physiologic, anatomic, or immunologic defect, which would interfere withresolution of this episode of acute otitis media.

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

• Known, severe renal impairment (i.e., creatinine clearance < 30 mUmid1.73 m2).

• History of Augmentin-associated cholestatic jaundicehepatic dysfunction.