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

Johns Hopkins University

Status: Completed

Conditions: Streptococcal Infections; Pharyngitis

Treatments: Drug: Penicillin G, Benzathine; Drug: Amoxicillin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01156740

HRN-A-00-96-90006-00

Details and patient eligibility

About

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.

Enrollment: 558 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Intramuscular benzathine Penicillin G

Active Comparator group

Description:

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

Treatment:

Drug: Penicillin G, Benzathine

Amoxicillin

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin