NCT02332577 is a Phase 4 clinical trial of PRISTINAMYCIN XRP7263 in Pneumonia, sponsored by Sanofi.

Who is sponsoring NCT02332577?

NCT02332577 is sponsored by Sanofi.

What drugs are being tested in NCT02332577?

Interventions in NCT02332577: PRISTINAMYCIN XRP7263, Amoxicillin, Amoxicillin Placebo, PRISTINAMYCIN Placebo.

Is NCT02332577 still recruiting?

NCT02332577 is currently terminated. Last updated 8 May 2023.

Last reviewed 2023-05-08 · How we verify

NCT02332577

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Last updated 8 May 2023

What this trial tests

Phase 4 trial testing PRISTINAMYCIN XRP7263 in Pneumonia in 161 participants. Terminated before completion.

Timeline

30 April 2015

Primary endpoint
20 February 2023

20 February 2023

Quick facts

Lead sponsor	Sanofi
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	161
Start date	30 April 2015
Primary completion	20 February 2023
Estimated completion	20 February 2023
Sites	19 locations across Tunisia, France

Drugs / interventions tested

PRISTINAMYCIN XRP7263 — full drug profile →
Amoxicillin (amoxicillin) — full drug profile →
Amoxicillin Placebo
PRISTINAMYCIN Placebo — full drug profile →

Conditions studied

Pneumonia — all drugs for Pneumonia →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.
Schuetz P, Wirz Y, Sager R, Christ-Crain M, et al · · 2017 · cited 206× · PMID 29025194 · DOI 10.1002/14651858.cd007498.pub3
Pharmacotherapy of Lower Respiratory Tract Infections in Elderly-Focused on Antibiotics.
Liu Y, Zhang Y, Zhao W, Liu X, et al · · 2019 · cited 12× · PMID 31736751 · DOI 10.3389/fphar.2019.01237
Managing community acquired pneumonia in the elderly - the next generation of pharmacotherapy on the horizon.
Amalakuhan B, Echevarria KL, Restrepo MI. · · 2017 · cited 12× · PMID 28598693 · DOI 10.1080/14656566.2017.1340937

Verify or expand the search:

Other recruiting trials for Pneumonia

Currently open trials in the same condition.

NCT07453966 — Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mec · NA · recruiting
NCT07251465 — A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia · active not recruiting
NCT07311343 — Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia · Phase 4 · recruiting
NCT07298889 — High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS · NA · recruiting
NCT06911658 — Infectious Complications After Esophagectomy · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02332577 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 8 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02332577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing