A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

Study Overview
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Brief Summary
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The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children

Conditions
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Tonsillitis

Intervention / Treatment
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* Drug: amoxicillin
* Drug: azithromycin SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae (strawberry tongue). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS. Exclusion Criteria: Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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<br>* 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours<br>|
| Experimental: 2<br> | Drug: azithromycin SR<br>* 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population |  | TOC visit (Day 24-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit |  | LTFU Visit (Day 38-45) | 
| Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population |  | TOC Visit (Day 24-28) | 
| Clinical response (cure or relapse) at the LTFU visit |  | LTFU Visit (Day 38-45) | 
| Pathogen susceptibility versus bacteriologic response |  | Not reported | 
| Adverse events (AEs) were assessed for all treated subjects |  | Continuous | 
| Vital signs and physical examinations were recorded |  | Baseline and as necessary | 
| Clinical laboratory testing (hematology and blood chemistry) |  | As necessary | 
| Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose |  | Day 1 |