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

This study has been completed.
Sponsor:
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
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
  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:


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:
  • 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®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Mark C. Steinhoff, MD Johns Hopkins School of Public Health
  More Information

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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 09, 2014