Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
- Conditions
- Pneumonia
- Interventions
- Registration Number
- NCT02332577
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pristinamycin + Placebo Amoxicillin Placebo Pristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days. Pristinamycin + Placebo PRISTINAMYCIN XRP7263 Pristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days. Amoxicillin + Placebo PRISTINAMYCIN Placebo Amoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days. Amoxicillin + Placebo Amoxicillin Amoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days.
- Primary Outcome Measures
Name Time Method Percentage of patients cured established from the clinical course and pulmonary radiological course 5 to 9 days post-treatment
- Secondary Outcome Measures
Name Time Method Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels 5 to 9 days post-treatment Percentage of cured patients evaluated by bacteriological documentation for pneumococcus 5 to 9 days post-treatment Percentage of patients with relapse at Day 30 Proportion of patients with adverse events up to Day 30 Mortality rate at Day 30 Number of documented failures 5 to 9 days post-treatment
Trial Locations
- Locations (19)
Investigational Site Number :250010
🇫🇷Grenoble, France
Investigational Site Number :250029
🇫🇷Avoine, France
Investigational Site Number :250015
🇫🇷COLOMBES Cedex, France
Investigational Site Number :250023
🇫🇷Nantes, France
Investigational Site Number :250054
🇫🇷Monaco Cedex, France
Investigational Site Number :250032
🇫🇷La Riche, France
Investigational Site Number :250022
🇫🇷Paris, France
Investigational Site Number :250004
🇫🇷PRINGY Cedex, France
Investigational Site Number :788002
🇹🇳Ariana, Tunisia
Investigational Site Number :250031
🇫🇷Segre, France
Investigational Site Number :250001
🇫🇷Saint Priest en Jarez, France
Investigational Site Number :788001
🇹🇳Ariana, Tunisia
Investigational Site Number :250034
🇫🇷Tours, France
Investigational Site Number :788004
🇹🇳Ariana, Tunisia
Investigational Site Number :788005
🇹🇳Ariana, Tunisia
Investigational Site Number :788007
🇹🇳Monastir, Tunisia
Investigational Site Number :788011
🇹🇳Monastir, Tunisia
Investigational Site Number :788009
🇹🇳Sfax, Tunisia
Investigational Site Number :788014
🇹🇳La marsa, Tunisia