← Back to all trials
Recruiting
NCT07345325
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Conditions: Infective Endocarditis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 422
Sponsor: Nantes University Hospital
Location: CH metropole Savoie, Chambery, GHT Savoie-Belley, Site Aix les Bains Aix-les-Bains
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 Criteria
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 \ 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
Source: ClinicalTrials.gov (NCT07345325). StuddyBuddy aggregates publicly available trial information.