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

NCT01156740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2010-07-05

No results posted yet for this study

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.

Conditions

  • Streptococcal Infections
  • Pharyngitis

Interventions

DRUG

Penicillin G, Benzathine

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

DRUG

Amoxicillin

750 mg/QD

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • World Health Organization

    collaborator OTHER

  • Cairo University

    collaborator OTHER

  • University Hospital for Infectious Diseases, Croatia

    collaborator OTHER

  • Universidade Federal do Rio de Janeiro

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Mark C. Steinhoff, MD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2003-04-30
Completion
2003-04-30

Countries

  • Brazil
  • Croatia
  • Egypt

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01156740 on ClinicalTrials.gov