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

Launched by SANOFI · Jan 5, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

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.