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

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Study Type: Interventional

Study Design: Allocation: Randomized, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Study Primary Completion Date: April 2003

Intervention(s) in this Clinical Trial

• Drug: cefdinir (Omnicef)
  • oral suspension (7 mg/kg, ql2hr) for 5 days
• Drug: amoxicillin
  • oral suspension (45 mg/kg/day, q l2 hours) for 10 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Clinical Cure Rate
  • Time Frame: 9 days
    Safety Issue?: No

Secondary Measures

• Sustained Clinical Cure Rate
  • Time Frame: 28 days
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis, documented by medical history and physical examination, is acute otitis 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 acute perforation of the tympanic membrane).
• At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
• Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
• Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results

Exclusion Criteria:

• Previous enrollment in this study.
• Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
• Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, 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 for azithromycin) 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 a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
• Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality 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.

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 March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644943

Study ID Number: M02-541

ClinicalTrials.gov Identifier: NCT00644943

Health Authority: United States: Food and Drug Administration