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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-04-30

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.

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Detailed Description

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Conditions

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Streptococcal Infections Pharyngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intramuscular benzathine Penicillin G

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

Group Type ACTIVE_COMPARATOR

Penicillin G, Benzathine

Intervention Type DRUG

IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)

Amoxicillin

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

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

750 mg/QD

Interventions

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Penicillin G, Benzathine

IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)

Intervention Type DRUG

Amoxicillin

750 mg/QD

Intervention Type DRUG

Other Intervention Names

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Intramuscular Benzathine Penicillin G Beta-lactam antibiotics Amoxil® Trimox®

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No