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

Study on the Efficacy of Investigational Medications for Bacterial 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.

Updated on 08 May 2023. Study ID: NCT02332577

This study investigates the effectiveness of an investigational medication for treating bacterial pneumonia, a lung infection that can cause symptoms like fever, cough, and difficulty breathing. The study compares two different treatment plans to see which is more effective in reducing symptoms and preventing relapse.

Participants will receive either the investigational medication or another treatment. They will be monitored for changes in their symptoms and any adverse events. The study will also look at how well the treatments work against specific bacteria and track any relapses or deaths within 30 days of starting treatment.

  • Who can participate: Adults over 18 years old with community-acquired pneumonia and specific symptoms can join. Key factors include a PORT score of II or III and recent chest x-ray showing lung infiltrates.
  • Study details: Participants will take either the investigational medication or another treatment. They will be observed for any side effects and the effectiveness of the treatment against bacteria. A placebo is not used in this study.
  • Study Timelines: The study will last 1 month.