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

Pharyngitis Clinical Trial

— TOPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156740
• Other study ID #: HRN-A-00-96-90006-00
• Status: Completed
• Phase: N/A
• First received: July 2, 2010
• Last updated: July 2, 2010
• Start date: August 2001
• Est. completion date: April 2003

Study information

• Verified date: December 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchCroatia: Ethics CommitteeEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Infections

Intervention

Drug:
• Penicillin G, Benzathine
IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
• Amoxicillin
750 mg/QD

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro
Croatia	University Hospital for Infectious Diseases	Zagreb
Egypt	Cairo University	Cairo

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Cairo University, United States Agency for International Development (USAID), Universidade Federal do Rio de Janeiro, University Hospital for Infectious Diseases, Croatia, World Health Organization

Countries where clinical trial is conducted

Brazil,  Croatia,  Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of Group A Streptococcus (GAS)	The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture.	21-28 days after 1st visit	Yes
Secondary	Compliance to treatment	Compliance with the amoxicillin treatment regimen was assessed at the follow up visit. The primary measure of compliance was the presence of antimicrobial activity in the urine-impregnated filter paper strips. For those who did not return the filter paper strip, compliance was measured by parent/guardian report during the exit interview. Patients who did not fulfill at least one of these criteria were considered noncompliant.	21-28 days after 1st visit	No