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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: PRISTINAMYCIN XRP7263
* Drug: Amoxicillin
* Drug: Amoxicillin Placebo
* Drug: PRISTINAMYCIN Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pristinamycin + Placebo<br>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. | Drug: PRISTINAMYCIN XRP7263<br>* Pharmaceutical form:tablet 500 mg Route of administration: oral<br>* Other names: Pyostacine ®;Drug: Amoxicillin Placebo<br>* Pharmaceutical form: capsule Route of administration: oral<br>|
| Active Comparator: Amoxicillin + Placebo<br>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. | Drug: Amoxicillin<br>* Pharmaceutical form:capsule 500 mg Route of administration: oral<br>* Other names: Amoxicilline EG;Drug: PRISTINAMYCIN Placebo<br>* Pharmaceutical form:Tablet Route of administration: Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients cured established from the clinical course and pulmonary radiological course |  | 5 to 9 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mortality rate |  | at Day 30 | 
| Number of documented failures |  | 5 to 9 days post-treatment | 
| Proportion of patients with adverse events |  | up to Day 30 |