drugset / Trial / NCT01156740
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
Completed
558 enrolled
Johns Hopkins University
Cairo University · collabUnited States Agency for International Development (USAID) · collabUniversidade Federal do Rio de Janeiro · collabUniversity Hospital for Infectious Diseases, Croatia · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2001-08
- Primary completion
- 2003-04
- Completion
- 2003-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 750 mg | Oral |
| Comparator | Benzylpenicillin | Unknown | 600000 iu | Intramuscular |
| Comparator | Benzylpenicillin | Unknown | 1.2e+06 iu | Intramuscular |