Official Title: “A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis”

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
  • amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
• Drug: azithromycin SR
  • azithromycin SR 60 mg/kg x 1 dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• clinical response (cure or failure) in the Clinical Per Protocol population
  • Time Frame: Test of Cure (TOC) visit (Day 12-14)
    Safety Issue?: No

Secondary Measures

• summary of baseline susceptibilities
  • Time Frame: Study endpoint
    Safety Issue?: No
• clinical response (cure or failure) in the Clinical Per Protocol population
  • Time Frame: On-Treatment (OT) visit (Day 4-6)
    Safety Issue?: No
• Laboratory abnormalities
  • Time Frame: Baseline and TOC visit
    Safety Issue?: Yes
• bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes
• clinical response (cure or failure) in all populations except the Clinical Per Protocol population
  • Time Frame: OT visit and TOC visit
    Safety Issue?: No
• clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population
  • Time Frame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)
    Safety Issue?: No
• clinical response (cure or failure) in the Clinical Per Protocol population
  • Time Frame: LTFU visit
    Safety Issue?: No
• clinical scores for the Clinical Per Protocol population
  • Time Frame: OT visit and TOC visit
    Safety Issue?: No
• persistence of middle ear fluid for the Clinical Per Protocol population
  • Time Frame: TOC visit and LTFU visit
    Safety Issue?: No
• audiologic response
  • Time Frame: LTFU visit
    Safety Issue?: No

Inclusion Criteria:

• Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included

Exclusion Criteria:

• Patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 48 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643292

Study ID Number: A0661073

ClinicalTrials.gov Identifier: NCT00643292

Health Authority: United States: Food and Drug Administration

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