Terminated

Phase 4
Age: 18Years +
All Genders
ID02332577

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

Led by Sanofi · Updated on 2023-05-08

161

Participants Needed

19

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 19 locations

1

Investigational Site Number :250029

Avoine, France, 37420

Status Unknown

2

Investigational Site Number :250015

Colombes, France, 92701

Status Unknown

3

Investigational Site Number :250010

Grenoble, France, 38043

Status Unknown

4

Investigational Site Number :250032

La Riche, France, 37520

Status Unknown

5

Investigational Site Number :250054

Monaco Cedex, France, 98012

Status Unknown

6

Investigational Site Number :250023

Nantes, France, 44093

Status Unknown

7

Investigational Site Number :250022

Paris, France, 75010

Status Unknown

8

Investigational Site Number :250004

Pringy, France, 74374

Status Unknown

9

Investigational Site Number :250001

Saint-Priest-en-Jarez, France, 42277

Status Unknown

10

Investigational Site Number :250031

Segré, France, 49500

Status Unknown

11

Investigational Site Number :250034

Tours, France, 37000

Status Unknown

12

Investigational Site Number :788001

Aryanah, Tunisia

Status Unknown

13

Investigational Site Number :788002

Aryanah, Tunisia

Status Unknown

14

Investigational Site Number :788004

Aryanah, Tunisia

Status Unknown

15

Investigational Site Number :788005

Aryanah, Tunisia

Status Unknown

16

Investigational Site Number :788014

La Marsa, Tunisia

Status Unknown

17

Investigational Site Number :788007

Monastir, Tunisia, 5000

Status Unknown

18

Investigational Site Number :788011

Monastir, Tunisia, 5000

Status Unknown

19

Investigational Site Number :788009

Sfax, Tunisia

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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