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Could skipping a common antibiotic be just as safe for heart infections?

NCT ID NCT07345325

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study compares two antibiotic approaches for a serious heart valve infection caused by staph bacteria. One group gets a standard treatment that includes the drug rifampin, while the other group gets a treatment without it. The goal is to see if skipping rifampin is just as effective at preventing death within six months. The trial plans to enroll 422 adults with infected prosthetic heart valves.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rifampin
What this could lead to
If successful, this could show that a simpler antibiotic regimen without rifampin is just as effective, reducing side effects and drug interactions for patients with this heart infection.
What could go wrong
This is a non-inferiority trial, so it may only prove the rifampin-free regimen is not worse, not better. The infection is serious, and treatment failure could be life-threatening.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 422 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial endocarditis endocarditis infective endocarditis staphylococcal infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infective endocarditis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP hôpital St Antoine

    RECRUITING

    Paris, 75012, France

  • AP-HP, Groupe hospitalier Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • AP-HP, Hôpital Pitié Salpétrière

    RECRUITING

    Paris, 75013, France

  • AP-HP, hôpital Bichat-Claude Bernard

    NOT_YET_RECRUITING

    Paris, 75018, France

  • CH Pau

    RECRUITING

    Pau, 64000, France

  • CH Tourcoing

    RECRUITING

    Tourcoing, 59200, France

  • CH intercommunal Cornouaille Quimper

    RECRUITING

    Quimper, 29000, France

  • CH metropole Savoie, Chambery, GHT Savoie-Belley, Site Aix les Bains

    RECRUITING

    Aix-les-Bains, 73100, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, 85000, France

  • CHR Orléans

    NOT_YET_RECRUITING

    Orléans, 45067, France

  • CHU Angers

    RECRUITING

    Angers, 49933, France

  • CHU Besançon

    NOT_YET_RECRUITING

    Besançon, 25030, France

  • CHU Bordeaux, Cardiologic hospital of Haut lévêque

    RECRUITING

    Bordeaux, 33600, France

  • CHU Bordeaux, Haut Lévêque Hospital, Infectious disease department

    RECRUITING

    Bordeaux, 33600, France

  • CHU Brest

    RECRUITING

    Brest, 29200, France

  • CHU Dijon Bourgogne

    RECRUITING

    Dijon, 21000, France

  • CHU Grenoble

    RECRUITING

    Grenoble, 38043, France

  • CHU Lyon, La Croix-Rousse Hospital, Infective disease department

    NOT_YET_RECRUITING

    Lyon, 69317, France

  • CHU Lyon, Louis Pradel Hospital, Cardiology Institute

    NOT_YET_RECRUITING

    Lyon, 69677, France

  • CHU Montpellier

    RECRUITING

    Montpellier, 34090, France

  • CHU Nancy

    RECRUITING

    Nancy, 54035, France

  • CHU Nantes, Hôtel Dieu Hospital, Infective disease department

    RECRUITING

    Nantes, 44093, France

  • CHU Nantes, Laennec Hospital, Cardiology department

    RECRUITING

    Nantes, 44800, France

  • CHU Nice

    RECRUITING

    Nice, 06202, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86000, France

  • CHU Rennes

    RECRUITING

    Rennes, 35000, France

  • CHU St-Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42270, France

  • CHU Strasbourg

    RECRUITING

    Strasbourg, 67000, France

  • CHU Toulouse, Purpan Hospital, Infectious disease department

    RECRUITING

    Toulouse, 31059, France

  • CHU Toulouse, Rangueil Hospital, Cardiology department

    RECRUITING

    Toulouse, 31400, France

  • CHU Tours

    RECRUITING

    Tours, 37044, France

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