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

NCT02332577

TerminatedPhase 4

Sponsor: Sanofi

Conditions: Pneumonia

Interventions: PRISTINAMYCIN XRP7263, Amoxicillin, Amoxicillin Placebo, PRISTINAMYCIN Placebo

Countries: France, Tunisia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (19)

Avoine, France
Colombes, France
Grenoble, France
La Riche, France
Monaco Cedex, France
Nantes, France
Paris, France
Pringy, France
Saint-Priest-en-Jarez, France
Segré, France
Tours, France
Aryanah, Tunisia
Aryanah, Tunisia
Aryanah, Tunisia
Aryanah, Tunisia
La Marsa, Tunisia
Monastir, Tunisia
Monastir, Tunisia
Sfax, Tunisia