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

Primary Purpose

Pneumonia

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PRISTINAMYCIN XRP7263
Amoxicillin
Amoxicillin Placebo
PRISTINAMYCIN Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational Site Number :250029
  • Investigational Site Number :250015
  • Investigational Site Number :250010
  • Investigational Site Number :250032
  • Investigational Site Number :250054
  • Investigational Site Number :250023
  • Investigational Site Number :250022
  • Investigational Site Number :250004
  • Investigational Site Number :250001
  • Investigational Site Number :250031
  • Investigational Site Number :250034
  • Investigational Site Number :788001
  • Investigational Site Number :788002
  • Investigational Site Number :788004
  • Investigational Site Number :788005
  • Investigational Site Number :788014
  • Investigational Site Number :788007
  • Investigational Site Number :788011
  • Investigational Site Number :788009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pristinamycin + Placebo

Amoxicillin + Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Percentage of patients cured established from the clinical course and pulmonary radiological course

Secondary Outcome Measures

Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Percentage 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

Full Information

First Posted
January 5, 2015
Last Updated
May 5, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02332577
Brief Title
Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
The sponsor stopped the study due to low recruitment with no safety concerns
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pristinamycin + Placebo
Arm Type
Experimental
Arm 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.
Arm Title
Amoxicillin + Placebo
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PRISTINAMYCIN XRP7263
Other Intervention Name(s)
Pyostacine ®
Intervention Description
Pharmaceutical form:tablet 500 mg Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxicilline EG
Intervention Description
Pharmaceutical form:capsule 500 mg Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Placebo
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
PRISTINAMYCIN Placebo
Intervention Description
Pharmaceutical form:Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
Percentage of patients cured established from the clinical course and pulmonary radiological course
Time Frame
5 to 9 days post-treatment
Secondary Outcome Measure Information:
Title
Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Time Frame
5 to 9 days post-treatment
Title
Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
Time Frame
5 to 9 days post-treatment
Title
Percentage of patients with relapse
Time Frame
at Day 30
Title
Mortality rate
Time Frame
at Day 30
Title
Number of documented failures
Time Frame
5 to 9 days post-treatment
Title
Proportion of patients with adverse events
Time Frame
up to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :250029
City
Avoine
ZIP/Postal Code
37420
Country
France
Facility Name
Investigational Site Number :250015
City
COLOMBES Cedex
ZIP/Postal Code
92701
Country
France
Facility Name
Investigational Site Number :250010
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Investigational Site Number :250032
City
La Riche
ZIP/Postal Code
37520
Country
France
Facility Name
Investigational Site Number :250054
City
Monaco Cedex
ZIP/Postal Code
98012
Country
France
Facility Name
Investigational Site Number :250023
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :250022
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Investigational Site Number :250004
City
PRINGY Cedex
ZIP/Postal Code
74374
Country
France
Facility Name
Investigational Site Number :250001
City
Saint Priest en Jarez
ZIP/Postal Code
42277
Country
France
Facility Name
Investigational Site Number :250031
City
Segre
ZIP/Postal Code
49500
Country
France
Facility Name
Investigational Site Number :250034
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Investigational Site Number :788001
City
Ariana
Country
Tunisia
Facility Name
Investigational Site Number :788002
City
Ariana
Country
Tunisia
Facility Name
Investigational Site Number :788004
City
Ariana
Country
Tunisia
Facility Name
Investigational Site Number :788005
City
Ariana
Country
Tunisia
Facility Name
Investigational Site Number :788014
City
La marsa
Country
Tunisia
Facility Name
Investigational Site Number :788007
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Investigational Site Number :788011
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Investigational Site Number :788009
City
Sfax
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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