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

May 5, 2023 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avoine, France, 37420
        • Investigational Site Number :250029
      • COLOMBES Cedex, France, 92701
        • Investigational Site Number :250015
      • Grenoble, France, 38043
        • Investigational Site Number :250010
      • La Riche, France, 37520
        • Investigational Site Number :250032
      • Monaco Cedex, France, 98012
        • Investigational Site Number :250054
      • Nantes, France, 44093
        • Investigational Site Number :250023
      • PRINGY Cedex, France, 74374
        • Investigational Site Number :250004
      • Paris, France, 75010
        • Investigational Site Number :250022
      • Saint Priest en Jarez, France, 42277
        • Investigational Site Number :250001
      • Segre, France, 49500
        • Investigational Site Number :250031
      • Tours, France, 37000
        • Investigational Site Number :250034
  • Tunisia
      • Ariana, Tunisia
        • Investigational Site Number :788001
      • Ariana, Tunisia
        • Investigational Site Number :788002
      • Ariana, Tunisia
        • Investigational Site Number :788004
      • Ariana, Tunisia
        • Investigational Site Number :788005
      • La marsa, Tunisia
        • Investigational Site Number :788014
      • Monastir, Tunisia, 5000
        • Investigational Site Number :788007
      • Monastir, Tunisia, 5000
        • Investigational Site Number :788011
      • Sfax, Tunisia
        • Investigational Site Number :788009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients cured established from the clinical course and pulmonary radiological course
Time Frame: 5 to 9 days post-treatment
5 to 9 days post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Time Frame: 5 to 9 days post-treatment
5 to 9 days post-treatment
Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
Time Frame: 5 to 9 days post-treatment
5 to 9 days post-treatment
Percentage of patients with relapse
Time Frame: at Day 30
at Day 30
Mortality rate
Time Frame: at Day 30
at Day 30
Number of documented failures
Time Frame: 5 to 9 days post-treatment
5 to 9 days post-treatment
Proportion of patients with adverse events
Time Frame: up to Day 30
up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2015

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRISTL06562
  • U1111-1160-6001 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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