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

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    500
  • sponsor
    Sanofi
Updated on 13 May 2022
pneumonia
amoxicillin
procalcitonin
community acquired pneumonia

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.

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.

Details
Condition Pneumonia
Treatment Amoxicillin, PRISTINAMYCIN XRP7263, Amoxicillin Placebo, PRISTINAMYCIN Placebo
Clinical Study IdentifierNCT02332577
SponsorSanofi
Last Modified on13 May 2022

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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