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

NCT02332577 | Terminated Phase 4 DMC

• 2 other identifiers: PRISTL06562U1111-1160-6001
• Study Type: interventional
• Target: 161
• Locations: 2 countries
• Sites: 19

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

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

  5 to 9 days post-treatment

Secondary Outcomes (6)

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

  5 to 9 days post-treatment

• Percentage of cured patients evaluated by bacteriological documentation for pneumococcus

  5 to 9 days post-treatment

• Percentage of patients with relapse

  at Day 30

• Mortality rate

  at Day 30

• Number of documented failures

  5 to 9 days post-treatment

Study Arms (2)

Pristinamycin + Placebo

EXPERIMENTAL

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; Drug: Amoxicillin Placebo

Amoxicillin + Placebo

ACTIVE COMPARATOR

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; Drug: PRISTINAMYCIN Placebo

Interventions

PRISTINAMYCIN XRP7263 DRUG

Pharmaceutical form:tablet 500 mg Route of administration: oral

Also known as: Pyostacine ®

Pristinamycin + Placebo

Amoxicillin DRUG

Pharmaceutical form:capsule 500 mg Route of administration: oral

Also known as: Amoxicilline EG

Amoxicillin + Placebo

Amoxicillin Placebo DRUG

Pharmaceutical form: capsule Route of administration: oral

Pristinamycin + Placebo

PRISTINAMYCIN Placebo DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Amoxicillin + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (19)

Investigational Site Number :250029

Avoine, 37420, France

Location

Investigational Site Number :250015

Colombes, 92701, France

Location

Investigational Site Number :250010

Grenoble, 38043, France

Location

Investigational Site Number :250032

La Riche, 37520, France

Location

Investigational Site Number :250054

Monaco Cedex, 98012, France

Location

Investigational Site Number :250023

Nantes, 44093, France

Location

Investigational Site Number :250022

Paris, 75010, France

Location

Investigational Site Number :250004

Pringy, 74374, France

Location

Investigational Site Number :250001

Saint-Priest-en-Jarez, 42277, France

Location

Investigational Site Number :250031

Segré, 49500, France

Location

Investigational Site Number :250034

Tours, 37000, France

Location

Investigational Site Number :788001

Aryanah, Tunisia

Location

Investigational Site Number :788002

Aryanah, Tunisia

Location

Investigational Site Number :788004

Aryanah, Tunisia

Location

Investigational Site Number :788005

Aryanah, Tunisia

Location

Investigational Site Number :788014

La Marsa, Tunisia

Location

Investigational Site Number :788007

Monastir, 5000, Tunisia

Location

Investigational Site Number :788011

Monastir, 5000, Tunisia

Location

Investigational Site Number :788009

Sfax, Tunisia

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Pristinamycin; Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptogramins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: April 30, 2015
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (8); FR (11)