NCT01156740

Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Streptococcal Infections
• Pharyngitis

Interventions

Type	Name	Description
DRUG	Penicillin G, Benzathine	IM BPG; 600,000 U \> 27kg or 1,200,000 U \<27 kg)
DRUG	Amoxicillin	750 mg/QD

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2010-07-05
• Last updated: 2010-07-05

Locations

3 sites across 3 countries: Brazil, Croatia, Egypt