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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02332577
Collaborator
(none)
500
Enrollment
19
Locations
2
Arms
121
Anticipated Duration (Months)
26.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PRISTINAMYCIN XRP7263
  • Drug: Amoxicillin
  • Drug: Amoxicillin Placebo
  • Drug: PRISTINAMYCIN Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 30, 2015
Anticipated Primary Completion Date :
May 30, 2025
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pristinamycin + Placebo

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.

Drug: PRISTINAMYCIN XRP7263
Pharmaceutical form:tablet 500 mg Route of administration: oral
Other Names:
  • Pyostacine ®

    • Drug: Amoxicillin Placebo
    Pharmaceutical form: capsule Route of administration: oral
    Active Comparator: Amoxicillin + Placebo

    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.

    Drug: Amoxicillin
    Pharmaceutical form:capsule 500 mg Route of administration: oral
    Other Names:
  • Amoxicilline EG

    • Drug: PRISTINAMYCIN Placebo
    Pharmaceutical form:Tablet Route of administration: Oral

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients cured established from the clinical course and pulmonary radiological course [5 to 9 days post-treatment]

    Secondary Outcome Measures

    1. Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels [5 to 9 days post-treatment]

    2. Percentage of cured patients evaluated by bacteriological documentation for pneumococcus [5 to 9 days post-treatment]

    3. Percentage of patients with relapse [at Day 30]

    4. Mortality rate [at Day 30]

    5. Number of documented failures [5 to 9 days post-treatment]

    6. Proportion of patients with adverse events [up to Day 30]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :250029 Avoine France 37420
    2 Investigational Site Number :250015 COLOMBES Cedex France 92701
    3 Investigational Site Number :250010 Grenoble France 38043
    4 Investigational Site Number :250032 La Riche France 37520
    5 Investigational Site Number :250054 Monaco Cedex France 98012
    6 Investigational Site Number :250023 Nantes France 44093
    7 Investigational Site Number :250022 Paris France 75010
    8 Investigational Site Number :250004 PRINGY Cedex France 74374
    9 Investigational Site Number :250001 Saint Priest en Jarez France 42277
    10 Investigational Site Number :250031 Segre France 49500
    11 Investigational Site Number :250034 Tours France 37000
    12 Investigational Site Number :788001 Ariana Tunisia
    13 Investigational Site Number :788002 Ariana Tunisia
    14 Investigational Site Number :788004 Ariana Tunisia
    15 Investigational Site Number :788005 Ariana Tunisia
    16 Investigational Site Number :788014 La marsa Tunisia
    17 Investigational Site Number :788007 Monastir Tunisia 5000
    18 Investigational Site Number :788011 Monastir Tunisia 5000
    19 Investigational Site Number :788009 Sfax Tunisia

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT02332577
    Other Study ID Numbers:
    • PRISTL06562
    • U1111-1160-6001
    First Posted:
    Jan 7, 2015
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 5, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Pneumonia
    Amoxicillin
    Pristinamycin

    Study Results

    No Results Posted as of Jul 6, 2022