drugset / Trial / NCT02332577

Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia

NCT02332577

Phase 4 Terminated 161 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: To evaluate the clinical efficacy of pristinamycin at a dose of 2g x 2/day for 2 days then 1g x 3/day for 5 to 7 days versus amoxicillin 1g x3 /day for 7 to 9 days, 5 to 9 days after the end of treatment. Secondary Objectives: To evaluate the clinical efficacy in a subpopulation bacteriologically documented at inclusion and according to procalcitonin level. To evaluate the efficacy of treatments against pneumococcus. To evaluate the rate of relapse and mortality 30±2 days after treatment is started. To document failures. To collect and follow up adverse events.

Timeline

Start
2015-04-30
Primary completion
2023-02-20
Completion
2023-02-20

Drugs

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

Indications