Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings

Study Overview
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Brief Summary
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The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.

Official Title
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Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries

Conditions
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Streptococcal Infections, Pharyngitis

Intervention / Treatment
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* Drug: Penicillin G, Benzathine
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 2-12 years old, Presenting with complaint of sore throat Parental consent given and child assent if 5 years or older Exclusion Criteria: The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening Had a history of rheumatic fever or rheumatic heart disease Required hospitalization for any reason at the time of enrollment Had previously been enrolled in the study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intramuscular benzathine Penicillin G<br>A single dose of intramuscularly administered intramuscular benzathine penicillin G (IM BPG). The dosing was as follows: IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg | Drug: Penicillin G, Benzathine<br>* IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)<br>* Other names: Beta-lactam antibiotics;|
| Active Comparator: Amoxicillin<br>A 10-day once daily dose of Amoxicillin was given in an oral form. The first dose was given at the time of randomization, and parents were instructed on giving the remaining doses. Dosing was as follows: 750 mg/QD | Drug: Amoxicillin<br>* 750 mg/QD<br>* Other names: Trimox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of Group A Streptococcus (GAS) | The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture. | 21-28 days after 1st visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to treatment | Compliance with the amoxicillin treatment regimen was assessed at the follow up visit. The primary measure of compliance was the presence of antimicrobial activity in the urine-impregnated filter paper strips. For those who did not return the filter paper strip, compliance was measured by parent/guardian report during the exit interview. Patients who did not fulfill at least one of these criteria were considered noncompliant. | 21-28 days after 1st visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.