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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02332577
• Other study ID #: PRISTL06562
• Secondary ID: U1111-1160-6001
• Status: Terminated
• Phase: Phase 4
• Start date: April 30, 2015
• Est. completion date: February 20, 2023

Study information

• Verified date: May 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 161
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Investigational Site Number :250029	Avoine
France	Investigational Site Number :250015	COLOMBES Cedex
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 Cedex
France	Investigational Site Number :250001	Saint Priest en Jarez
France	Investigational Site Number :250031	Segre
France	Investigational Site Number :250034	Tours
Tunisia	Investigational Site Number :788001	Ariana
Tunisia	Investigational Site Number :788002	Ariana
Tunisia	Investigational Site Number :788004	Ariana
Tunisia	Investigational Site Number :788005	Ariana
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

France,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients cured established from the clinical course and pulmonary radiological course		5 to 9 days post-treatment
Secondary	Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels		5 to 9 days post-treatment
Secondary	Percentage of cured patients evaluated by bacteriological documentation for pneumococcus		5 to 9 days post-treatment
Secondary	Percentage of patients with relapse		at Day 30
Secondary	Mortality rate		at Day 30
Secondary	Number of documented failures		5 to 9 days post-treatment
Secondary	Proportion of patients with adverse events		up to Day 30