Official Title: “A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media”

To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment

Study Primary Completion Date: January 2004

Intervention(s) in this Clinical Trial

• Drug: cefdinir (Omnicef)
  • oral suspension, 7 mg/kg every 12 hours for 5 days
• Drug: azithromycin
  • oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Clinical cure rate at Evaluation 2
  • Time Frame: 9 days
    Safety Issue?: No

Secondary Measures

• Sustained clinical cure rate at Evaluation 4
  • Time Frame: 25 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645112

Study ID Number: M03-630

ClinicalTrials.gov Identifier: NCT00645112

Health Authority: United States: Food and Drug Administration