Title
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
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
Phase
N/ALead Sponsor
Johns Hopkins UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Pharyngitis Streptococcal InfectionsIntervention/Treatment
procaine benzylpenicillin benzathine penicillin ...Study Participants
558The 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.
IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
750 mg/QD
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
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
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
