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

Investigation of the Efficacy of an Investigational Medication Versus Amoxicillin for Acute Community Acquired Pneumonia

Not Recruiting
18 years or above
All
Phase 4
161 participants needed

Study Overview

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.

Study Details

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pneumonia
  • Age: 18 years or above
  • Gender: All

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.

The purpose of this study is to investigate the effectiveness of an investigational medication compared to amoxicillin in treating acute community acquired pneumonia. The study will evaluate how well the investigational medication works in reducing symptoms and preventing relapse compared to the standard treatment with amoxicillin.

Participants will receive either the investigational medication or amoxicillin. The investigational medication will be administered as 2g twice daily for two days, followed by 1g three times daily for five to seven days. Amoxicillin will be given as 1g three times daily for seven to nine days. The study will also monitor participants for any adverse events and the recurrence of pneumonia symptoms.

  • Who can participate: Adults over the age of 18 with a presumed bacterial acute community acquired pneumonia and a PORT score of II or III are eligible. Key factors include a recent pulmonary x-ray showing new infiltrates and symptoms like fever, cough, or chest pain.
  • Study details: Participants will be assigned to receive either the investigational medication or amoxicillin. They will be monitored for adverse events and treatment effectiveness. The study will also assess the rate of relapse and mortality.
  • Study timelines: The study will last 1 month.
Updated on 08 May 2023. Study ID: NCT02332577