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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


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


Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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