Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
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- STATUS
- Recruiting
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- End date
- May 30, 2025
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- participants needed
- 500
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- sponsor
- Sanofi
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 Identifier | NCT02332577 |
| Sponsor | Sanofi |
| Last Modified on | 25 May 2022 |
Eligibility
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