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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Media

Treatments: Drug: amoxicillin/clavulanate postassium (Augmentin ES-600); Drug: azithromycin SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643292

A0661073

Details and patient eligibility

About

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

Enrollment: 902 patients

Sex: All

Ages: 3 to 48 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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902 participants in 2 patient groups

1

Experimental group

Treatment:

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

2

Experimental group

Treatment:

Drug: azithromycin SR