Terminated
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
Eligibility Criteria
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.
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
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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