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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
558
IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)
750 mg/QD
Federal University of Rio de Janeiro
Rio de Janeiro, Brazil
University Hospital for Infectious Diseases
Zagreb, Croatia
Cairo University
Cairo, Egypt
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.
Time frame: 21-28 days after 1st visit
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.
Time frame: 21-28 days after 1st visit
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