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

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

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.

Study Overview

• Status: Completed
• Conditions: Streptococcal Infections; Pharyngitis
• Intervention / Treatment: Drug: Penicillin G, Benzathine; Drug: Amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Federal University of Rio de Janeiro
• Croatia
  • Zagreb, Croatia
    • University Hospital for Infectious Diseases
• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intramuscular benzathine Penicillin G; A single dose of intramuscularly administered intramuscular benzathine penicillin G (IM BPG). The dosing was as follows: IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg	Drug: Penicillin G, Benzathine; IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg); Other Names: Intramuscular Benzathine Penicillin G; Beta-lactam antibiotics
ACTIVE_COMPARATOR: Amoxicillin; A 10-day once daily dose of Amoxicillin was given in an oral form. The first dose was given at the time of randomization, and parents were instructed on giving the remaining doses. Dosing was as follows: 750 mg/QD	Drug: Amoxicillin; 750 mg/QD; Other Names: Amoxil®; Trimox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Cairo University; United States Agency for International Development (USAID); World Health Organization; Universidade Federal do Rio de Janeiro; University Hospital for Infectious Diseases, Croatia
• Investigators: Principal Investigator: Mark C. Steinhoff, MD, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (ACTUAL): April 1, 2003
• Study Completion (ACTUAL): April 1, 2003

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (ESTIMATE): July 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 5, 2010
• Last Update Submitted That Met QC Criteria: July 2, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: randomized clinical trial; amoxicillin; streptococcal pharyngitis; intramuscular benzathine penicillin G.
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pharyngitis; Streptococcal Infections; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin; Penicillins; Penicillin G Benzathine; Penicillin G; Penicillin G Procaine; beta-Lactams
• Other Study ID Numbers: HRN-A-00-96-90006-00