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

Pneumonia Clinical Trial

Official title:
A Multi-centre, Non-inferiority, Randomized, Double-blind, Phase IV Study Comparing Pristinamycin (2g x 2 Per Day for 2 Days Then 1g x 3 Per Day for 5 to 7 Days) to Amoxicillin (1g x 3 Per Day) for 7 to 9 Days in Adults With Acute Community Acquired Pneumonia With a PORT Score of II or III

Clinical Trial 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.

Clinical Trial Description

The total study duration for each patient is 1 month with a treatment period of 7 to 9 days and a follow-up period of 21 to 23 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02332577
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 4
Start date April 30, 2015
Completion date February 20, 2023
View Details
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