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A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 19, 2008
Last updated: May 16, 2011
Last verified: May 2011
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

Condition Intervention Phase
Acute Otitis Media
Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
Drug: azithromycin SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 12-14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: On-Treatment (OT) visit (Day 4-6) ] [ Designated as safety issue: No ]
  • Laboratory abnormalities [ Time Frame: Baseline and TOC visit ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • clinical response (cure or failure) in all populations except the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: LTFU visit ] [ Designated as safety issue: No ]
  • clinical scores for the Clinical Per Protocol population [ Time Frame: OT visit and TOC visit ] [ Designated as safety issue: No ]
  • persistence of middle ear fluid for the Clinical Per Protocol population [ Time Frame: TOC visit and LTFU visit ] [ Designated as safety issue: No ]
  • audiologic response [ Time Frame: LTFU visit ] [ Designated as safety issue: No ]

Enrollment: 902
Study Start Date: January 2003
Study Completion Date: May 2004
Arms Assigned Interventions
Experimental: 1 Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
Experimental: 2 Drug: azithromycin SR
azithromycin SR 60 mg/kg x 1 dose


Ages Eligible for Study:   3 Months to 48 Months   (Child)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00643292

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00643292     History of Changes
Other Study ID Numbers: A0661073 
Study First Received: March 19, 2008
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 18, 2017