Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prost… (NCT07345325) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
France422 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 rif…