Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis: a Multicenter Randomized Controlled Non-inferiority Study
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to demonstrate that a rifampin-free regimen is non-inferior to the rifampin-containing regimen in terms of all-cause mortality in staphylococcal prosthetic valve endocarditis within 6 months after randomization.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Definite infective endocarditis according to the 2023 Duke ISCVID criteria or confirmed by the endocarditis team if the endocarditis was classified as possible
• Prosthetic valve endocarditis
• At least one positive blood culture due to Staphylococcus sp (S. aureus or CoNS)
• After the first positive blood culture, at least one negative blood culture (after a minimum of 72 hours of incubation)
• Infective endocarditis due to Staphylococcus sp (S. aureus or coagulase negative staphylococci) susceptible to rifampin
• Antistaphylococcal treatment for endocarditis introduced less than 14 days ago. We do not consider all antibiotic received before the first positive blood culture
• Age ≥ 18-year-old
• Informed, written consent obtained from patient or from patient's near in kin
• Patient insured under a health insurance scheme
• Patient with adequate contraceptive measure
Locations
Other Locations
France
CH metropole Savoie, Chambery, GHT Savoie-Belley, Site Aix les Bains
NOT_YET_RECRUITING
Aix-les-bains
CHU Angers
RECRUITING
Angers
CHU Besançon
NOT_YET_RECRUITING
Besançon
CHU Bordeaux, Cardiologic hospital of Haut lévêque
NOT_YET_RECRUITING
Bordeaux
CHU Bordeaux, Haut Lévêque Hospital, Infectious disease department
NOT_YET_RECRUITING
Bordeaux
CHU Brest
RECRUITING
Brest
AP-HP, Groupe hospitalier Henri Mondor
NOT_YET_RECRUITING
Créteil
CHU Dijon Bourgogne
RECRUITING
Dijon
CHU Grenoble
RECRUITING
Grenoble
CHD Vendée
RECRUITING
La Roche-sur-yon
CHU Lyon, La Croix-Rousse Hospital, Infective disease department
NOT_YET_RECRUITING
Lyon
CHU Lyon, Louis Pradel Hospital, Cardiology Institute
NOT_YET_RECRUITING
Lyon
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
CHU Nancy
NOT_YET_RECRUITING
Nancy
CHU Nantes, Hôtel Dieu Hospital, Infective disease department
RECRUITING
Nantes
CHU Nantes, Laennec Hospital, Cardiology department
RECRUITING
Nantes
CHU Nice
RECRUITING
Nice
CHR Orléans
NOT_YET_RECRUITING
Orléans
AP-HP hôpital St Antoine
NOT_YET_RECRUITING
Paris
AP-HP, hôpital Bichat-Claude Bernard
NOT_YET_RECRUITING
Paris
AP-HP, Hôpital Pitié Salpétrière
NOT_YET_RECRUITING
Paris
CH Pau
RECRUITING
Pau
CHU Poitiers
RECRUITING
Poitiers
CH intercommunal Cornouaille Quimper
NOT_YET_RECRUITING
Quimper
CHU Rennes
NOT_YET_RECRUITING
Rennes
CHU St-Etienne
NOT_YET_RECRUITING
Saint-etienne
CHU Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU Toulouse, Purpan Hospital, Infectious disease department
NOT_YET_RECRUITING
Toulouse
CHU Toulouse, Rangueil Hospital, Cardiology department
NOT_YET_RECRUITING
Toulouse
CH Tourcoing
RECRUITING
Tourcoing
CHU Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Raphaël LECOMTE, MD
raphael.lecomte@chu-nantes.fr
02 40 08 31 12
Time Frame
Start Date:2026-06-11
Estimated Completion Date:2031-06-11
Participants
Target number of participants:422
Treatments
Experimental: Rifampin-free regimen.
The experimental arm of the study involves the removal of rifampicin from the antibiotic regimen recommended by the 2023 ESC (European Society of Cardiology) guidelines and the 2025 French guidelines (AEPEI/SPILF) for the treatment of staphylococcal prosthetic valve endocarditis.
Active_comparator: Rifampin containing regimen
Rifampin containing regimen (900 mg/day). Antibiotic treatment of endocarditis in accordance with the 2023 ESC guidelines and the 2025 French guidelines (AEPEI/SPILF).