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Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children

NCT00393744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2009-03-17

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the non-inferiority, at the assessment visit (V3 (D10/D14)), in terms of bacteriological efficacy of pristinamycin (PRI) administered for 4 days versus amoxicillin (AMX) administered for 6 days in the treatment of tonsillitis caused by GAS, in subjects aged between 6 and 25 in the per protocol (PP) group.

Conditions

  • Tonsillitis

Interventions

DRUG

pristinamycin

50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days

DRUG

amoxicillin

50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days

Sponsors & Collaborators

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-03-31

Countries

  • France

Study Locations

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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 NCT00393744 on ClinicalTrials.gov