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

  • End date
    May 31, 2021
  • participants needed
  • sponsor
Updated on 6 September 2020
For site information, send an email with site number to
Primary Contact
Investigational Site Number 250029 (0.0 mi away) Contact
+58 other location
chest pain
community acquired pneumonia


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 302 days after treatment is started.

To document failures. To collect and follow up adverse events.


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.

Treatment Amoxicillin, PRISTINAMYCIN XRP7263, Amoxicillin Placebo, PRISTINAMYCIN Placebo
Clinical Study IdentifierNCT02332577
Last Modified on6 September 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Pulmonary Disease or Pneumonia or Throat and Tonsil Infections or Lung Disease or Pneumonia (Pediatric) or Upper respiratory infection?
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
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
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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet