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Completed

NCT Number: NCT01156740

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

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.

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Key information

Conditions

Streptococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro, Rio de Janeiro, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penicillin G, Benzathine

Drug

IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)

Other names: Intramuscular Benzathine Penicillin G, Beta-lactam antibiotics

Amoxicillin

Drug

750 mg/QD

Other names: Amoxil®, Trimox®

Primary outcomes

  1. Eradication of Group A Streptococcus (GAS)

    Time frame: 21-28 days after 1st visit

    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 outcomes

  1. Compliance to treatment

    Time frame: 21-28 days after 1st visit

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study 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

Acronym: TOPS

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Jul 5, 2010
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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