NCT01156740

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2001

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
Last Updated

July 5, 2010

Status Verified

December 1, 2009

Enrollment Period

1.7 years

First QC Date

July 2, 2010

Last Update Submit

July 2, 2010

Conditions

Streptococcal InfectionsPharyngitis

Keywords

streptococcal pharyngitisrandomized clinical trialamoxicillinintramuscular benzathine penicillin G.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Compliance to treatment

    21-28 days after 1st visit

Study Arms (2)

Intramuscular benzathine Penicillin G

ACTIVE COMPARATOR

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

Amoxicillin

ACTIVE COMPARATOR

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

Interventions

Penicillin G, BenzathineDRUG

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

Also known as: Intramuscular Benzathine Penicillin G, Beta-lactam antibiotics
Intramuscular benzathine Penicillin G
AmoxicillinDRUG

750 mg/QD

Also known as: Amoxil®, Trimox®
Amoxicillin

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 2-12 years old,
  • Presenting with complaint of sore throat
  • Parental consent given and child assent if 5 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Federal University of Rio de Janeiro

Rio de Janeiro, Brazil

Location

University Hospital for Infectious Diseases

Zagreb, Croatia

Location

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Streptococcal InfectionsPharyngitis

Interventions

Penicillin Gbeta Lactam AntibioticsAmoxicillin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnti-Bacterial AgentsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesAmpicillin

Study Officials

  • Mark C. Steinhoff, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

August 1, 2001

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

July 5, 2010

Record last verified: 2009-12

Locations

CR(1)EG(1)BR(1)