Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
NCT ID: NCT02332577
Last Updated: 2023-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
161 participants
INTERVENTIONAL
2015-04-30
2023-02-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pristinamycin + Placebo
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.
PRISTINAMYCIN XRP7263
Pharmaceutical form:tablet 500 mg Route of administration: oral
Amoxicillin Placebo
Pharmaceutical form: capsule Route of administration: oral
Amoxicillin + Placebo
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.
Amoxicillin
Pharmaceutical form:capsule 500 mg Route of administration: oral
PRISTINAMYCIN Placebo
Pharmaceutical form:Tablet Route of administration: Oral
Interventions
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PRISTINAMYCIN XRP7263
Pharmaceutical form:tablet 500 mg Route of administration: oral
Amoxicillin
Pharmaceutical form:capsule 500 mg Route of administration: oral
Amoxicillin Placebo
Pharmaceutical form: capsule Route of administration: oral
PRISTINAMYCIN Placebo
Pharmaceutical form:Tablet Route of administration: Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :250029
Avoine, , France
Investigational Site Number :250015
Colombes, , France
Investigational Site Number :250010
Grenoble, , France
Investigational Site Number :250032
La Riche, , France
Investigational Site Number :250054
Monaco Cedex, , France
Investigational Site Number :250023
Nantes, , France
Investigational Site Number :250022
Paris, , France
Investigational Site Number :250004
Pringy, , France
Investigational Site Number :250001
Saint-Priest-en-Jarez, , France
Investigational Site Number :250031
Segré, , France
Investigational Site Number :250034
Tours, , France
Investigational Site Number :788001
Aryanah, , Tunisia
Investigational Site Number :788002
Aryanah, , Tunisia
Investigational Site Number :788004
Aryanah, , Tunisia
Investigational Site Number :788005
Aryanah, , Tunisia
Investigational Site Number :788014
La Marsa, , Tunisia
Investigational Site Number :788007
Monastir, , Tunisia
Investigational Site Number :788011
Monastir, , Tunisia
Investigational Site Number :788009
Sfax, , Tunisia
Countries
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Other Identifiers
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U1111-1160-6001
Identifier Type: OTHER
Identifier Source: secondary_id
PRISTL06562
Identifier Type: -
Identifier Source: org_study_id
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