Pneumonia
Conditions
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.
Interventions
DRUGPRISTINAMYCIN XRP7263
Pharmaceutical form:tablet 500 mg Route of administration: oral
DRUGAmoxicillin
Pharmaceutical form:capsule 500 mg Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
DRUGPRISTINAMYCIN Placebo
Pharmaceutical form:Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female more than 18 years old with a presumed bacterial acute community acquired pneumonia presenting a PORT score of II or III (Fine II or III). The acute community acquired pneumonia is defined by: * Pulmonary x-ray (carried out within the 48 hours prior to randomization) showing new lobar or multilobar infiltrates. * At least 4 functional and/or clinical symptoms from among the following: * Fever characterized by a temperature of more than 38.5 at least once within 24h prior to inclusion. * Appearance or aggravation of a cough. * Appearance of purulent expectoration. * Appearance or aggravation of dyspnoea. * Tachypnoea * Chest pain * A characteristic sign on percussion and/or auscultation associated with a pulmonary condensation focus.
Exclusion criteria
Patients having been diagnosed with legionellosis. Patients having received systemic antibiotic therapy of over 24 hours within the week preceding the start of study treatment. Associated neoplasm (active cancer \[of whatever type, solid or haematological\] or diagnosed within the year other than basocellular skin cancer). Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD3 and GOLD4). History of bacterial pneumonia in the past 12 months. Bronchopulmonary diseases likely to interfere with the assessment of the therapeutic response. Known hypersensitivity to streptogramins, penicillin and other betalactamines or excipients of the treatments studied. History of severe skin reaction after taking pristinamycin or amoxicillin. Kidney disease (chronic kidney failure or creatinine clearance ≤30 mL/minute). Patients treated with allopurinol, colchicine, immunosuppressants (cyclosporin, tacrolimus, mycophenolate mofetil, methotrexate, biotherapies) oral anticoagulants in the previous 6 months or during the study. Known HIV infection, whatever the stage. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients cured established from the clinical course and pulmonary radiological course | 5 to 9 days post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of cured patients evaluated by bacteriological documentation for pneumococcus | 5 to 9 days post-treatment |
| Percentage of patients with relapse | at Day 30 |
| Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels | 5 to 9 days post-treatment |
| Number of documented failures | 5 to 9 days post-treatment |
| Proportion of patients with adverse events | up to Day 30 |
| Mortality rate | at Day 30 |
Countries
France, Tunisia
Outcome results
None listed