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

NCT07345325

RecruitingPhase 3

Sponsor: Nantes University Hospital

Conditions: Infective Endocarditis

Interventions: Rifampin-free regimen, Rifampin containing regimen

Countries: France

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<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
Locations (31)
  • Aix-les-Bains, France
  • Angers, France
  • Besançon, France
  • Bordeaux, France
  • Bordeaux, France
  • Brest, France
  • Créteil, France
  • Dijon, France
  • Grenoble, France
  • La Roche-sur-Yon, France
  • Lyon, France
  • Lyon, France
  • Montpellier, France
  • Nancy, France
  • Nantes, France
  • Nantes, France
  • Nice, France
  • Orléans, France
  • Paris, France
  • Paris, France
  • Paris, France
  • Pau, France
  • Poitiers, France
  • Quimper, France
  • Rennes, France
  • Saint-Etienne, France
  • Strasbourg, France
  • Toulouse, France
  • Toulouse, France
  • Tourcoing, France
  • + 1 more on CT.gov