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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Cairo University; United States Agency for International Development (USAID); Universidade Federal do Rio de Janeiro; University Hospital for Infectious Diseases, Croatia; World Health Organization
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; beta-Lactams; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

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