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

ConditionInfective Endocarditis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rifampin-free regimen

    Drug

    Rifampin-free regimen. The choice of other antibiotics is at the discretion of the physicians in charge but should be in accordance with the 2023 ESC guidelines and 2025 French guidelines (AEPEI/SPILF).

  • Rifampin containing regimen

    Drug

    Rifampin containing regimen (900 mg/day). Antibiotic treatment of endocarditis in accordance with the 2023 ESC guidelines and 2025 French guidelines.

Treatment groups

422 Participants
are divided into 2 treatment groups
Group A: Rifampin-free regimen.Experimental treatment 1 intervention
Group B: Rifampin containing regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality rate at 6 months

Deaths of all causes from randomizaton until 6 months

Time frame
Up to 6 months

Secondary outcomes

1

Microbiological failure

Proportions of patients with at least one microbiological failure defined by bacteremia with the primary pathogen obtained during follow-up but before the end of curative treatment.

Time frame
Up to 6 months
2

Relapse

Proportions of patients with at least one relapse defined by bacteremia with the primary pathogen obtained during follow-up after the end of treatment of endocarditis until 6 months, then until 12 months.

Time frame
Up to 12 months
3

Clinically evident embolic event

Proportions of patients with at least one clinically evident embolic event (defined as secondary osteoarticular, splenic, brain or other symptomatic localizations) from randomization until 6 months.

Time frame
Up to 6 months
4

Valvular surgery

Proportions of patients with at least one valvular surgery at 6 months and at 12 months

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Source ClinicalTrials.gov
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