NCT02332577

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	PRISTINAMYCIN XRP7263	Pharmaceutical form:tablet 500 mg Route of administration: oral
DRUG	Amoxicillin	Pharmaceutical form:capsule 500 mg Route of administration: oral
DRUG	Amoxicillin Placebo	Pharmaceutical form: capsule Route of administration: oral
DRUG	PRISTINAMYCIN Placebo	Pharmaceutical form:Tablet Route of administration: Oral

Timeline

• Start date: 2015-04-30
• Primary completion: 2023-02-20
• Completion: 2023-02-20
• First posted: 2015-01-07
• Last updated: 2023-05-08

Locations

19 sites across 2 countries: France, Tunisia