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

Pfizer1 site902 target enrollmentJanuary 2003

ConditionsAcute Otitis Media

Interventionsamoxicillin/clavulanate postassium (Augmentin ES-600)azithromycin SR

Drugsamoxicillin/clavulanate postassium (Augmentin ES-600)azithromycin SR

Overview

Phase: Phase 3
Intervention: amoxicillin/clavulanate postassium (Augmentin ES-600)
Conditions: Acute Otitis Media
Sponsor: Pfizer
Enrollment: 902
Locations: 1
Primary Endpoint: clinical response (cure or failure) in the Clinical Per Protocol population
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

May 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: amoxicillin/clavulanate postassium (Augmentin ES-600)

2

Intervention: azithromycin SR

Outcomes

Primary Outcomes

clinical response (cure or failure) in the Clinical Per Protocol population

Time Frame: Test of Cure (TOC) visit (Day 12-14)

Secondary Outcomes

summary of baseline susceptibilities(Study endpoint)
clinical response (cure or failure) in the Clinical Per Protocol population(LTFU visit)
Laboratory abnormalities(Baseline and TOC visit)
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population(TOC visit)
adverse events(Continuous)
clinical response (cure or failure) in all populations except the Clinical Per Protocol population(OT visit and TOC visit)
clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population(OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32))
clinical scores for the Clinical Per Protocol population(OT visit and TOC visit)
persistence of middle ear fluid for the Clinical Per Protocol population(TOC visit and LTFU visit)
audiologic response(LTFU visit)