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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia

Intervention: PRISTINAMYCIN XRP7263 (Drug); Amoxicillin (Drug); Amoxicillin Placebo (Drug); PRISTINAMYCIN Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Overall contact:
For site information, send an email with site number to, Email: Contact-Us@sanofi.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of patients cured established from the clinical course and pulmonary radiological course

Secondary outcome:

Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels

Percentage of cured patients evaluated by bacteriological documentation for pneumococcus

Percentage of patients with relapse

Mortality rate

Number of documented failures

Proportion of patients with 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

For site information, send an email with site number to, Email: Contact-Us@sanofi.com

250013, Antony, France; Recruiting

250014, Bagnols-sur-Cèze, France; Recruiting

250019, Chauny, France; Recruiting

250025, Clamart, France; Recruiting

250015, Colombes, France; Recruiting

250018, Coudray, France; Recruiting

250005, Dijon, France; Recruiting

250010, Grenoble, France; Recruiting

250020, Le Mans CEDEX 9, France; Recruiting

250006, Lille, France; Recruiting

250023, Nantes, France; Recruiting

250022, Paris, France; Recruiting

250004, Pringy, France; Recruiting

250001, Saint Priest en Jarez, France; Recruiting

250021, Tours, France; Recruiting

250002, Vandoeuvre Les Nancy, France; Recruiting

Additional Information

Starting date: January 2015
Last updated: April 15, 2015

Page last updated: August 23, 2015

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