Inclusion Criteria:
- Clinical diagnosis, documented by medical history and physical examination, is AOM I 1
week.
- Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may be
expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be
based on reports from parents or legally authorized representatives; Discharge from
the 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 or
bulging or perforated tympanic membrane, which may be erythematous (note - since
hyperemia may be present in a febrile or crying child, a red tympanic membrane alone
is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks
(opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic
pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane
and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by
acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
- Generally in good health based on medical history, vital signs, physical exam, and
historical 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 unapproved
doses; in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other
macrolide 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 1
or during the study.
- Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G
benzathine) 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 with
resolution of this episode of acute otitis media.
- Immunocompromised subject (e.g., neutropenic subjects).
- Presence of a disease, complicating factor (e.g., mastoiditis), or structural
abnormality that would preclude evaluation of the subject's therapeutic response.
- Any expectation that treatment with probenecid will be expected during the study drug
administration period.
- Known significant renal or hepatic impairment.
