PneumoniaPhase 4NCT02332577
Study to Compare the Efficacy of Pristinamycin (Pyostacine ®) Versus Amoxicillin in the Treatment of Acute Community Acquired Pneumonia
A Phase 4 study testing PRISTINAMYCIN XRP7263 and Amoxicillin in people with Pneumonia, run by Sanofi at 19 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- PRISTINAMYCIN XRP7263 and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 30 Apr 2015to 20 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France11 sites
Investigational Site Number :250029
Avoine, 37420
Investigational Site Number :250015
Colombes, 92701
Investigational Site Number :250010
Grenoble, 38043
Investigational Site Number :250032
La Riche, 37520
Investigational Site Number :250054
Monaco Cedex, 98012
Investigational Site Number :250023
Nantes, 44093
Investigational Site Number :250022
Paris, 75010
Investigational Site Number :250004
Pringy, 74374
Investigational Site Number :250001
Saint-Priest-en-Jarez, 42277
Investigational Site Number :250031
Segré, 49500
Investigational Site Number :250034
Tours, 37000
Tunisia8 sites
Investigational Site Number :788001
Aryanah
Investigational Site Number :788002
Aryanah
Investigational Site Number :788004
Aryanah
Investigational Site Number :788005
Aryanah
Investigational Site Number :788014
La Marsa
Investigational Site Number :788007
Monastir, 5000
Investigational Site Number :788011
Monastir, 5000
Investigational Site Number :788009
Sfax
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- PRISTINAMYCIN XRP7263, Amoxicillin, Amoxicillin Placebo, PRISTINAMYCIN Placebo
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISTINAMYCIN XRP7263Drug
Also called Pyostacine ®
Pharmaceutical form:tablet 500 mg Route of administration: oral
AmoxicillinDrug
Also called Amoxicilline EG
Pharmaceutical form:capsule 500 mg Route of administration: oral
Amoxicillin PlaceboDrug
Pharmaceutical form: capsule Route of administration: oral
PRISTINAMYCIN PlaceboDrug
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Pristinamycin + Placebo | Experimental | Pristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days. Receives: Drug: PRISTINAMYCIN XRP7263; Drug: Amoxicillin Placebo |
| Amoxicillin + Placebo | Active comparator | Amoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days. Receives: Drug: Amoxicillin; Drug: PRISTINAMYCIN Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients cured established from the clinical course and pulmonary radiological course
Measured: 5 to 9 days post-treatment
Secondary outcomes (6)
Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Measured: 5 to 9 days post-treatment
Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
Measured: 5 to 9 days post-treatment
Percentage of patients with relapse
Measured: at Day 30
Mortality rate
Measured: at Day 30
Number of documented failures
Measured: 5 to 9 days post-treatment
Proportion of patients with adverse events
Measured: up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start30 Apr 2015
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Why it stopped: The sponsor stopped the study due to low recruitment with no safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332577
- Sponsor's protocol ID
- PRISTL06562
- Other IDs
- U1111-1160-6001
- Status last verified
- May 2023
- First submitted
- 5 Jan 2015
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02332577
- Acronym / sponsor ID
- PRISTL06562
- Conditions
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor stopped the study due to low recruitment with no safety concerns
- Enrolment
- 161 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pristinamycin + Placebo | Experimental | Drug: PRISTINAMYCIN XRP7263, Drug: Amoxicillin PlaceboPristinamycin: 500 mg tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days Amoxicillin Placebo: capsule, 2 capsules x 3 /day for 7 to 9 days. |
| Amoxicillin + Placebo | Active comparator | Drug: Amoxicillin, Drug: PRISTINAMYCIN PlaceboAmoxicillin: 500 mg capsule, 2 capsules x 3/day for 7 to 9 days Pristinamycin Placebo: tablet, 4 tablets x 2/day for 2 days then 2 tablets x 3/day for 5 to 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISTINAMYCIN XRP7263Also: Pyostacine ®Pharmaceutical form:tablet 500 mg Route of administration: oral | Drug | Pristinamycin + Placebo |
| AmoxicillinAlso: Amoxicilline EGPharmaceutical form:capsule 500 mg Route of administration: oral | Drug | Amoxicillin + Placebo |
| Amoxicillin PlaceboPharmaceutical form: capsule Route of administration: oral | Drug | Pristinamycin + Placebo |
| PRISTINAMYCIN PlaceboPharmaceutical form:Tablet Route of administration: Oral | Drug | Amoxicillin + Placebo |
Primary outcome
Percentage of patients cured established from the clinical course and pulmonary radiological course
Time frame: 5 to 9 days post-treatment
6 secondary outcomes
Percentage of cured patients evaluated by bacteriological documentation and procalcitonin levels
Time frame: 5 to 9 days post-treatment
Percentage of cured patients evaluated by bacteriological documentation for pneumococcus
Time frame: 5 to 9 days post-treatment
Percentage of patients with relapse
Time frame: at Day 30
Mortality rate
Time frame: at Day 30
Number of documented failures
Time frame: 5 to 9 days post-treatment
Proportion of patients with adverse events
Time frame: up to Day 30
Results and safety
The study was stopped early (reason given: The sponsor stopped the study due to low recruitment with no safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRISTINAMYCIN XRP7263 and Amoxicillin in people with Pneumonia, run by Sanofi at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The sponsor stopped the study due to low recruitment with no safety concerns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients cured established from the clinical course and pulmonary radiological course (time frame: 5 to 9 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.