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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Pneumonia

Treatments: Drug: Amoxicillin; Drug: Amoxicillin Placebo; Drug: PRISTINAMYCIN XRP7263; Drug: PRISTINAMYCIN Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332577

U1111-1160-6001 (Other Identifier)

PRISTL06562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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161 participants in 2 patient groups

Pristinamycin + Placebo

Experimental group

Description:

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.

Treatment:

Drug: PRISTINAMYCIN XRP7263

Drug: Amoxicillin Placebo

Amoxicillin + Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Amoxicillin

Drug: PRISTINAMYCIN Placebo