Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: PRISTINAMYCIN XRP7263 (Drug); Amoxicillin (Drug); Amoxicillin Placebo (Drug); PRISTINAMYCIN Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Clinical Sciences & Operations, Study Director, Affiliation: Sanofi
Overall contact: For site information, send an email with site number to, Email: Contact-Us@sanofi.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of patients cured established from the clinical course and pulmonary radiological course
Secondary outcome: Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levelsPercentage of cured patients evaluated by bacteriological documentation for pneumococcus Percentage of patients with relapse Mortality rate Number of documented failures Proportion of patients with 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 and Contacts
For site information, send an email with site number to, Email: Contact-Us@sanofi.com
250013, Antony, France; Recruiting
250014, Bagnols-sur-Cèze, France; Recruiting
250019, Chauny, France; Recruiting
250025, Clamart, France; Recruiting
250015, Colombes, France; Recruiting
250018, Coudray, France; Recruiting
250005, Dijon, France; Recruiting
250010, Grenoble, France; Recruiting
250020, Le Mans CEDEX 9, France; Recruiting
250006, Lille, France; Recruiting
250023, Nantes, France; Recruiting
250022, Paris, France; Recruiting
250004, Pringy, France; Recruiting
250001, Saint Priest en Jarez, France; Recruiting
250021, Tours, France; Recruiting
250002, Vandoeuvre Les Nancy, France; Recruiting
Additional Information
Starting date: January 2015
Last updated: April 15, 2015
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