NCT00393744

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

A Phase III, Open, Randomised, Multicentre Study Comparing the Efficacy and Safety of Pristinamycin, at Dosages of 50 mg/kg/d in 2 Doses for Children, and 1g Twice Daily in Adults for 4 Days Versus Amoxicillin at a Dosage of 50 mg/kg/d in 2 Doses in Children and 1 g Twice Daily in Adults for 6 Days, Consumed Orally, in the Treatment of Tonsillitis Induced by Group-A Beta-Haemolytic Streptococcus in Patients Aged Between 6 and 25 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• First posted: 2006-10-30
• Last updated: 2009-03-17

Locations

1 site across 1 country: France