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

Study 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

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

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
* Drug: azithromycin SR


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 48 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)<br>* amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days<br>|
| Experimental: 2<br> | Drug: azithromycin SR<br>* azithromycin SR 60 mg/kg x 1 dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| summary of baseline susceptibilities |  | Study endpoint | 
| 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 | 
| 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 response (cure or failure) in the Clinical Per Protocol population |  | LTFU visit | 
| 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 |