Pharyngitis Clinical Trial
— TOPSOfficial title:
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
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.
Status | Completed |
Enrollment | 558 |
Est. completion date | April 2003 |
Est. primary completion date | April 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 12 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Rio de Janeiro | Rio de Janeiro | |
Croatia | University Hospital for Infectious Diseases | Zagreb | |
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Cairo University, United States Agency for International Development (USAID), Universidade Federal do Rio de Janeiro, University Hospital for Infectious Diseases, Croatia, World Health Organization |
Brazil, Croatia, Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 21-28 days after 1st visit | Yes |
Secondary | 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. | 21-28 days after 1st visit | No |
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