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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
Pharmaceutical form:tablet 500 mg Route of administration: oral
Pharmaceutical form:capsule 500 mg Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form:Tablet Route of administration: Oral
Investigational Site Number :250029
Avoine, France
Investigational Site Number :250015
Colombes, France
Investigational Site Number :250010
Grenoble, France
Investigational Site Number :250032
La Riche, France
Investigational Site Number :250054
Monaco Cedex, France
Investigational Site Number :250023
Nantes, France
Investigational Site Number :250022
Paris, France
Investigational Site Number :250004
Pringy, France
Investigational Site Number :250001
Saint-Priest-en-Jarez, France
Investigational Site Number :250031
Segré, France
...and 9 more locations
Percentage of patients cured established from the clinical course and pulmonary radiological course
Time frame: 5 to 9 days post-treatment
Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Time frame: 5 to 9 days post-treatment
Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
Time frame: 5 to 9 days post-treatment
Percentage of patients with relapse
Time frame: at Day 30
Mortality rate
Time frame: at Day 30
Number of documented failures
Time frame: 5 to 9 days post-treatment
Proportion of patients with adverse events
Time frame: up to Day 30
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