Clinical trial NCT02332577: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pneumonia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of patients cured established from the clinical course and pulmonary radiological course
timeFrame: 5 to 9 days post-treatment
Secondary outcomes:
measure: Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
timeFrame: 5 to 9 days post-treatment
measure: Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
timeFrame: 5 to 9 days post-treatment
measure: Percentage of patients with relapse
timeFrame: at Day 30
measure: Mortality rate
timeFrame: at Day 30
measure: Number of documented failures
timeFrame: 5 to 9 days post-treatment
measure: Proportion of patients with adverse events
timeFrame: up to Day 30
Other outcomes:
Locations:
city: Avoine
country: France
facility: Investigational Site Number :250029
city: COLOMBES Cedex
country: France
facility: Investigational Site Number :250015
city: Grenoble
country: France
facility: Investigational Site Number :250010
city: La Riche
country: France
facility: Investigational Site Number :250032
city: Monaco Cedex
country: France
facility: Investigational Site Number :250054
city: Nantes
country: France
facility: Investigational Site Number :250023
city: Paris
country: France
facility: Investigational Site Number :250022
city: PRINGY Cedex
country: France
facility: Investigational Site Number :250004
city: Saint Priest en Jarez
country: France
facility: Investigational Site Number :250001
city: Segre
country: France
facility: Investigational Site Number :250031
city: Tours
country: France
facility: Investigational Site Number :250034
city: Ariana
country: Tunisia
facility: Investigational Site Number :788001
city: Ariana
country: Tunisia
facility: Investigational Site Number :788002
city: Ariana
country: Tunisia
facility: Investigational Site Number :788004
city: Ariana
country: Tunisia
facility: Investigational Site Number :788005
city: La marsa
country: Tunisia
facility: Investigational Site Number :788014
city: Monastir
country: Tunisia
facility: Investigational Site Number :788007
city: Monastir
country: Tunisia
facility: Investigational Site Number :788011
city: Sfax
country: Tunisia
facility: Investigational Site Number :788009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: