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

  • STATUS
    Recruiting
  • End date
    May 31, 2021
  • participants needed
    500
  • sponsor
    Sanofi
Updated on 6 September 2020
Investigator
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fever
chest pain
amoxicillin
procalcitonin
dyspnea
x-rays
cough
community acquired pneumonia

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 302 days after treatment is started.

To document failures. To collect and follow up adverse events.

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.

Details
Treatment Amoxicillin, PRISTINAMYCIN XRP7263, Amoxicillin Placebo, PRISTINAMYCIN Placebo
Clinical Study IdentifierNCT02332577
SponsorSanofi
Last Modified on6 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Pulmonary Disease or Pneumonia or Throat and Tonsil Infections or Lung Disease or Pneumonia (Pediatric) or Upper respiratory infection?
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
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