Pharyngitis, Streptococcal Infections
Conditions
Keywords
streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.
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.
Interventions
IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)
DRUGAmoxicillin
750 mg/QD
Sponsors
United States Agency for International Development (USAID)
World Health Organization
Cairo University
University Hospital for Infectious Diseases, Croatia
Universidade Federal do Rio de Janeiro
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil, Croatia, Egypt
Outcome results
None listed