Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings (TOPS)
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborators:
United States Agency for International Development (USAID)
World Health Organization
Cairo University
University Hospital for Infectious Diseases, Croatia
Federal University of Rio de Janeiro
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01156740
First received: July 2, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
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Purpose
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.
Condition | Intervention |
---|---|
Streptococcal Infections Pharyngitis |
Drug: Penicillin G, Benzathine Drug: Amoxicillin |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Drug Information available for:
Penicillin G
Penicillin G Sodium
Penicillin G Potassium
Penicillin G Procaine
Amoxicillin sodium
Penicillin G benzathine
Amoxicillin
U.S. FDA Resources
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Eradication of Group A Streptococcus (GAS) [ Time Frame: 21-28 days after 1st visit ] [ Designated as safety issue: Yes ]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 [ Time Frame: 21-28 days after 1st visit ] [ Designated as safety issue: No ]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.
Enrollment: | 558 |
Study Start Date: | August 2001 |
Study Completion Date: | April 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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:
|
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:
|
Eligibility
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156740
Locations
Brazil | |
Federal University of Rio de Janeiro | |
Rio de Janeiro, Brazil | |
Croatia | |
University Hospital for Infectious Diseases | |
Zagreb, Croatia | |
Egypt | |
Cairo University | |
Cairo, Egypt |
Sponsors and Collaborators
Johns Hopkins University
United States Agency for International Development (USAID)
World Health Organization
Cairo University
University Hospital for Infectious Diseases, Croatia
Federal University of Rio de Janeiro
Investigators
Principal Investigator: | Mark C. Steinhoff, MD | Johns Hopkins School of Public Health |
More Information
No publications provided
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
Responsible Party: | Dr. Mark C. Steinhoff, Cincinnati Children's Hospital / Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT01156740 History of Changes |
Other Study ID Numbers: | HRN-A-00-96-90006-00 |
Study First Received: | July 2, 2010 |
Last Updated: | July 2, 2010 |
Health Authority: | Brazil: National Committee of Ethics in Research Croatia: Ethics Committee Egypt: Ministry of Health and Population |
Keywords provided by Johns Hopkins University:
streptococcal pharyngitis randomized clinical trial amoxicillin intramuscular benzathine penicillin G. |
Additional relevant MeSH terms:
Pharyngitis Streptococcal Infections Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Gram-Positive Bacterial Infections Bacterial Infections |
Amoxicillin Anti-Bacterial Agents Penicillin G Penicillin G Benzathine Penicillin G Procaine Beta-Lactams Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012