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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07345325). StuddyBuddy aggregates publicly available trial information.