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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643292

Enrollment

902

Registered

2008-03-26

Start date

2003-01-31

Completion date

2004-05-31

Last updated

2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media

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

Interventions

DRUGamoxicillin/clavulanate postassium (Augmentin ES-600)

amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days

DRUGazithromycin SR

azithromycin SR 60 mg/kg x 1 dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

3 Months to 48 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
clinical response (cure or failure) in the Clinical Per Protocol population	Test of Cure (TOC) visit (Day 12-14)

Secondary

Measure	Time frame
clinical response (cure or failure) in the Clinical Per Protocol population	On-Treatment (OT) visit (Day 4-6)
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
summary of baseline susceptibilities	Study endpoint
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
clinical response (cure or failure) in all populations except the Clinical Per Protocol population	OT visit and TOC visit

Countries

Argentina, Chile, Costa Rica, Dominican Republic, Estonia, Guatemala, Israel, Mexico, Panama, Poland, Russia, Slovakia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026