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

Primary Purpose

Streptococcal Infections, Pharyngitis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Penicillin G, Benzathine
Amoxicillin
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Streptococcal Infections focused on measuring streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Rio de Janeiro
  • University Hospital for Infectious Diseases
  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intramuscular benzathine Penicillin G

Amoxicillin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2010
Last Updated
July 2, 2010
Sponsor
Johns Hopkins University
Collaborators
United States Agency for International Development (USAID), World Health Organization, Cairo University, University Hospital for Infectious Diseases, Croatia, Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT01156740
Brief Title
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infections, Pharyngitis
Keywords
streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intramuscular benzathine Penicillin G
Arm Type
Active Comparator
Arm Description
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
Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Penicillin G, Benzathine
Other Intervention Name(s)
Intramuscular Benzathine Penicillin G, Beta-lactam antibiotics
Intervention Description
IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxil®, Trimox®
Intervention Description
750 mg/QD
Primary Outcome Measure Information:
Title
Eradication of Group A Streptococcus (GAS)
Description
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.
Time Frame
21-28 days after 1st visit
Secondary Outcome Measure Information:
Title
Compliance to treatment
Description
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.
Time Frame
21-28 days after 1st visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C. Steinhoff, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
Country
Brazil
Facility Name
University Hospital for Infectious Diseases
City
Zagreb
Country
Croatia
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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