Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis

Recruiting now · Phase 3

Conditions studied: Infective Endocarditis

In brief

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.

Key facts

Study ID

NCT07345325

Run by

Nantes University Hospital

People needed

422

Starts

2026-06-11

Expected to finish

2031-06-11

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Presence of cardiovascular implanted electronic device with suspected device-related IE without removal of the device
• Expected duration of follow-up <6 months at the time of randomization
• Patient moribund (expected to die in next 48 hours with or without treatment)
• Patients already receiving more than 72 hours of rifampin for the endocarditis treatment prior to randomization
• Positive blood cultures less than 72 hours before randomization
• Medical history of infective endocarditis in the last 3 months
• True allergy to rifampin or a severe intolerance to rifampin
• Contraindication to rifampin
• Patients requiring treatment contraindicated or not recommended with rifampin or incompatible with the inducer effect of rifampicin according to the marketing authorisation.
• ALAT increase greater than 3 times the upper laboratory range
• Extreme weight (< 45 kg or > 150 kg)
• Patients with confirmed prosthetic vascular graft infection or orthopedic-device-related infection
• Patients treated with rifampin for infections other than endocarditis, such as tuberculosis
• Pregnancy or breastfeeding woman
• Inclusion in another drug clinical trial
• Patients who have already been included in the study for a previous episode of endocarditis
• Patients under court protection, guardianship or trusteeship
• Patients who do not speak or understand French language
• Patient unable to collect information in a daily journal
• Patient unable to understand a follow-up by phone contact

Where it is running

• CHU Tours — Tours, France (enrolling)
• CHU Angers — Angers, France (enrolling)
• CHU Rennes — Rennes, France (enrolling)
• CHU Strasbourg — Strasbourg, France (enrolling)
• CHU Toulouse, Purpan Hospital, Infectious disease department — Toulouse, France (enrolling)
• CHU Toulouse, Rangueil Hospital, Cardiology department — Toulouse, France (enrolling)
• CH Tourcoing — Tourcoing, France (enrolling)
• CH metropole Savoie, Chambery, GHT Savoie-Belley, Site Aix les Bains — Aix-les-Bains, France (enrolling)
• CHU Bordeaux, Cardiologic hospital of Haut lévêque — Bordeaux, France (enrolling)
• CHU Bordeaux, Haut Lévêque Hospital, Infectious disease department — Bordeaux, France (enrolling)
• CHU Brest — Brest, France (enrolling)
• AP-HP, Groupe hospitalier Henri Mondor — Créteil, France (enrolling)
• CHU Dijon Bourgogne — Dijon, France (enrolling)
• CHU Grenoble — Grenoble, France (enrolling)
• CHD Vendée — La Roche-sur-Yon, France (enrolling)
• CHU Montpellier — Montpellier, France (enrolling)
• CHU Nancy — Nancy, France (enrolling)
• CHU Nantes, Hôtel Dieu Hospital, Infective disease department — Nantes, France (enrolling)
• CHU Nantes, Laennec Hospital, Cardiology department — Nantes, France (enrolling)
• CHU Nice — Nice, France (enrolling)
• AP-HP hôpital St Antoine — Paris, France (enrolling)
• AP-HP, Hôpital Pitié Salpétrière — Paris, France (enrolling)
• CH Pau — Pau, France (enrolling)
• CHU Poitiers — Poitiers, France (enrolling)
• CH intercommunal Cornouaille Quimper — Quimper, France (enrolling)

Full record on ClinicalTrials.gov

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