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Compares treatment options for Infective Endocarditis
Official title Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
ClinicalTrials.gov ID: NCT07345325
What this study is testing
What is Rifampin-free regimen?
Rifampin-free regimen is an investigational medicine, being studied as a potential treatment for infective endocarditis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Definite infective endocarditis according to the 2023 Duke ISCVID criteria or confirmed by the endocarditis team if the endocarditis was classified...
- 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
You likely can't join 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
See the full eligibility 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
- 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 (\ 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
The study team makes the final eligibility decision.
Where it's taking place
- Aix-les-Bains, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Créteil, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Lyon, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Orléans, France
- Paris, France
- Pau, France
- Poitiers, France
- Quimper, France
- Rennes, France
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aix-les-Bains, France; Angers, France; Besançon, France; Bordeaux, France; Brest, France; Créteil, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.