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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01156740
Other study ID # HRN-A-00-96-90006-00
Secondary ID
Status Completed
Phase N/A
First received July 2, 2010
Last updated July 2, 2010
Start date August 2001
Est. completion date April 2003

Study information

Verified date December 2009
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchCroatia: Ethics CommitteeEgypt: Ministry of Health and Population
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 558
Est. completion date April 2003
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 12 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Penicillin G, Benzathine
IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
Amoxicillin
750 mg/QD

Locations

Country Name City State
Brazil Federal University of Rio de Janeiro Rio de Janeiro
Croatia University Hospital for Infectious Diseases Zagreb
Egypt Cairo University Cairo

Sponsors (6)

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

Countries where clinical trial is conducted

Brazil,  Croatia,  Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 21-28 days after 1st visit Yes
Secondary 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. 21-28 days after 1st visit No
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