Comparing rifampin-free treatment versus rifampin in adults with staphylococcal prosthetic valve endocarditis

3 1 1 1

What is this study about?

This study focuses on treating staphylococcal prosthetic valve endocarditis, which is a serious infection of artificial heart valves caused by staphylococcus bacteria. The research compares two different treatment approaches: one using medications without rifampin and another that includes rifampin. The main purpose is to determine if treatment without rifampin works as well as treatment with rifampin in preventing deaths within 6 months of starting therapy.

The study medications include several antibiotics: ceftaroline fosamil, cefazolin, vancomycin, daptomycin, levofloxacin, and cotrimoxazole. Some patients will receive rifampin (either as Rifadine or Rimactan) while others will receive a placebo. The treatment will continue for up to 6 months, with different combinations of these medications given either by mouth or through an intravenous line.

During the study, doctors will monitor patients for signs of infection clearing, complications, and overall health status. They will check if the infection returns, if additional surgery is needed, and track any side effects from the medications. Patients will be followed for up to 12 months to ensure long-term effectiveness of the treatment.

1 Initial treatment phase

After joining the study, you will be randomly assigned to one of two treatment groups: a rifampin-free treatment or a rifampin-containing treatment.

The treatment will be administered through different methods, including: intravenous infusion (medication given through a vein) and oral medication (tablets or capsules).

The medications may include combinations of: ceftaroline, cefazolin, vancomycin, daptomycin, levofloxacin, sulfamethoxazole-trimethoprim, and rifampin (depending on assigned group).

2 Treatment monitoring

Your blood samples will be tested to ensure there is no infection in your blood (minimum 72 hours of testing).

The total duration of antibiotic treatment for your heart valve infection will be monitored and recorded.

Regular checks will be conducted for any side effects from the medication.

3 Follow-up period

Your health status will be monitored for 6 months after starting the study.

During this period, you will be checked for any signs of infection return, complications, or need for additional treatment.

The length of your hospital stay will be recorded.

4 Extended monitoring

Additional follow-up will continue for up to 12 months after starting the study.

Any hospital readmissions or additional treatments needed will be documented.

Your overall health status will continue to be monitored throughout this period.

5 Study completion

The study will evaluate your overall health outcome.

Any complications or additional treatments required during the study period will be documented.

The effectiveness of your assigned treatment will be assessed.

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have confirmed infective endocarditis (an infection of the heart’s inner lining and valves) according to specific medical criteria
  • Must have a prosthetic valve endocarditis (infection affecting an artificial heart valve)
  • Must have an infection caused by specific bacteria called Staphylococcus that can be treated with rifampin (an antibiotic medication)
  • Must have at least one positive blood test showing Staphylococcus bacteria, followed by a negative blood test after 72 hours
  • Must have started antibiotic treatment for the infection less than 14 days ago
  • Must have health insurance coverage
  • Must provide written informed consent to participate
  • For male participants:
    • Must agree to use condoms during the study and for several months after treatment ends
    • Must not donate sperm during this period
  • For female participants:
    • Must follow specific contraception requirements
    • Must not donate eggs during the study period
  • Partners of participants must also follow specific contraception requirements during the study period and for several months after treatment ends

Who Cannot Join the Study?

  • Age below 18 years old or above 85 years old
  • Pregnancy or breastfeeding women
  • Known allergy or hypersensitivity to any of the study medications
  • Severe liver disease (as it may affect how medications are processed in the body)
  • Severe kidney disease (as it may affect how medications are cleared from the body)
  • Participation in another clinical trial within the past 30 days
  • Having a staphylococcal infection (bacterial infection) in location other than heart valves
  • Having artificial heart valves made of materials not suitable for the study
  • Inability to follow study procedures or attend follow-up visits
  • Having other serious medical conditions that could interfere with the study treatment
  • History of drug-resistant staphylococcal infections (infections that don’t respond to standard antibiotics)
  • Taking medications that could interact with the study drugs
  • Mental conditions that could affect ability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier De Pau Pau France
Cnryqq Hnihdjdwuvv Rdlfzgvc Dswdcboeetqjzo Angers France
Cweskv Hlidxxzelsv Ujqcsvsasiwgc Dx Dsngp Dijon France
Baoeocti Uoiiocnfvg Hijikgvy Cstwtn Besançon France
Cmmnyn Hpmmaggtbsp Rzghgozh Uifbyjxxcihjp Dt Tnwxn Tours France
Clma Dx Npquf Vandoeuvre Les Nancy France
Cbn Cgqog Rimqcmrpdvp Lyon France
Ibftmgbc dc Cnponhvnxhou Hlwkemnwqjx Uvfwukhvskrss dj Smcon Edqczgt (ksxggvn Saint Priest En Jarez France
Hjxxsukb Uhvvylncwhzrry Shvomwcjhe &nxpwqm Hibfnou dr Hcpzwfzwdxi STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
18.08.2025

Trial locations

Rifampin is an antibiotic medication used to treat bacterial infections. It works by stopping the growth of bacteria. In this trial, it’s being studied as part of a treatment regimen for infections affecting artificial heart valves (prosthetic valve endocarditis) caused by staphylococcal bacteria.

The trial compares two treatment approaches: one that includes Rifampin and another treatment regimen that doesn’t contain Rifampin. This comparison aims to determine if treating the infection without Rifampin can be just as effective as using it in the treatment plan.

Staphylococcal Endocarditis – An infection of the heart’s inner lining (endocardium) and valves caused by Staphylococcus bacteria. The condition occurs when bacteria enter the bloodstream and attach to damaged areas of the heart valves or abnormal heart tissue. The infection leads to the formation of clumps of bacteria, cells, and other substances that create growths on the heart valves. These growths can damage the heart valves and interfere with normal blood flow through the heart. The infection can spread to other parts of the body through the bloodstream.

Prosthetic Valve Endocarditis – An infection that develops on or around artificial (prosthetic) heart valves that have been surgically implanted. This specific form of endocarditis occurs when bacteria colonize the prosthetic valve material and surrounding tissue. The infection can develop anywhere from a few months to several years after valve replacement surgery. The bacteria form colonies on the artificial valve, creating deposits that can interfere with the valve’s normal function.

Trial ID:
2024-518018-22-00
Protocol code:
RC24_0404
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Adjuvant mRNA-4157 and pembrolizumab for patients with completely resected high‑risk stage I non‑small cell lung cancer

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Hungary Italy The Netherlands +2
  • Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

    Recruiting

    2 1 1 1
    Investigated diseases:
    Czechia Denmark France Germany Hungary Ireland +4