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

Not Applicable

Completed

• Conditions: Streptococcal Infections; Pharyngitis
• Interventions: Drug: Penicillin G, Benzathine; Drug: Amoxicillin

• Registration Number: NCT01156740
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Status Verified: 2009-12
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Last Update Submitted: 2010-07-02
• Study First Posted: 2010-07-05
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular benzathine Penicillin G	Penicillin G, Benzathine	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
Amoxicillin	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

Primary Outcome Measures

Name	Time	Method
Eradication of Group A Streptococcus (GAS)	21-28 days after 1st visit	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.

Secondary Outcome Measures

Name	Time	Method
Compliance to treatment	21-28 days after 1st visit	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.

Trial Locations

Locations (3)

University Hospital for Infectious Diseases; 🇭🇷 Zagreb, Croatia

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

Cairo University; 🇪🇬 Cairo, Egypt