Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Streptococcal Infections; Pharyngitis
Intervention: Penicillin G, Benzathine (Drug); Amoxicillin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Mark C. Steinhoff, MD, Principal Investigator, Affiliation: Johns Hopkins School of Public Health
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Eradication of Group A Streptococcus (GAS)
Secondary outcome: Compliance to treatment
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
University Hospital for Infectious Diseases, Zagreb, Croatia
Cairo University, Cairo, Egypt
Additional Information
Starting date: August 2001
Last updated: July 2, 2010
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