drugset / Trial / NCT00393744

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

NCT00393744

Phase 3 Completed 395 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-10
Primary completion
2008-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 50 mg/kg Oral
Comparator Amoxicillin Other / unclassified 1 g Oral
Subject PRISTINAMYCIN Unknown 50 mg/kg Oral
Subject PRISTINAMYCIN Unknown 1 g Oral

Indications