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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

13 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

  • Ceftaroline fosamil

    This medication is an injectable solution administered through an infusion into a vein. It is a widely used antibiotic used to treat serious bacterial infections. At a molecular level, it works by attaching to and blocking the enzymes that bacteria need to build their protective cell walls, causing the bacteria to burst. It belongs to a class of drugs known as fifth-generation cephalosporins.

  • Cefazolin sodium

    This drug is administered via injection into a muscle or directly into a vein. It is a well-established antibiotic commonly used to prevent and treat various bacterial infections. It functions by interfering with the ability of bacteria to construct their cell walls, which leads to their destruction. It is classified as a first-generation cephalosporin antibiotic.

  • Vancomycin hydrochloride

    This substance can be taken orally or administered through an intravenous infusion. It is a standard treatment in medical practice for serious infections caused by specific resistant bacteria. It works by binding to the components of the bacterial cell wall, preventing the bacteria from maintaining their structure. It is classified as a glycopeptide antibiotic.

  • Rifampicin

    This medication is available as an intravenous infusion or in oral capsule form. It is a long-standing antibiotic used extensively to treat infections like tuberculosis and certain heart valve infections. It works by entering the bacteria and stopping them from producing essential proteins required for survival. It belongs to the rifamycin class of antibiotics.

  • Sulfamethoxazole and trimethoprim

    These two active ingredients are taken orally in the form of a tablet. This combination is a commonly prescribed antibiotic used to treat a variety of bacterial infections. The drugs work together to block two different stages of the bacteria's ability to produce folic acid, which is vital for their growth. This combination is classified as a sulfonamide-based antibiotic.

  • Daptomycin

    This medication is administered as an injection or infusion into a vein. It is an established antibiotic used to treat serious skin and blood infections caused by certain bacteria. It works by attaching to the bacterial cell membrane and creating holes, which causes the contents of the bacteria to leak out and die. It is classified as a cyclic lipopeptide antibiotic.

Investigated diseases

  • 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 detailsLast updated 27 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518018-22-00Protocol codeRC24_0404Estimated enrolment422 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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