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Study of Switching from Intravenous to Oral Antibiotics in Patients with Infective Endocarditis Using a Drug Combination

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What is this trial about?

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

This study involves patients with Infective Endocarditis, which is a serious infection affecting the inner lining of the heart chambers and heart valves. The infection can occur on natural heart valves or artificial ones that have been surgically implanted. The study will use several different antibiotics to treat this condition. These include gentamicin, which is given through an infusion into a vein, and a combination of amoxicillin with clavulanic acid taken by mouth. Other medications that may be used include amoxicillin alone, cefazolin, flucloxacillin, benzylpenicillin, and ceftriaxone, which are given through injections or infusions. Additional oral antibiotics include a combination of sulfamethoxazole with trimethoprim, moxifloxacin, clindamycin, rifampicin, and levofloxacin. The specific bacteria causing the infection will be identified through laboratory tests, and may include various types such as Streptococcus, Enterococcus, Staphylococcus, or other organisms.

The purpose of this study is to evaluate whether switching from antibiotics given through a vein to antibiotics taken by mouth earlier in the treatment process works as well as the standard longer treatment with intravenous antibiotics. The study will follow a standardized treatment plan that allows patients to switch to oral antibiotics after a short period of intravenous treatment. This approach aims to determine if patients can be treated effectively with oral medications, which would potentially allow them to complete treatment outside of the hospital setting while maintaining the same level of effectiveness in fighting the infection.

Patients participating in this study will initially receive intravenous antibiotics while admitted to the hospital for less than ten days. After this initial phase, if their condition is stable and the infection is responding to treatment, they may be switched to oral antibiotics according to the study protocol. Throughout the treatment period, which will last for up to six months, patients will be monitored for any signs that the infection is not responding, any complications, or side effects from the medications. The study will track various outcomes including survival, need for heart surgery, new infection-related complications, and patient satisfaction with the treatment approach. Blood samples will be collected at certain times to measure antibiotic levels and ensure the medications are working properly.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Your treatment will begin with intravenous antibiotics, which means the medication will be delivered directly into your vein through a drip. This initial phase will last for up to 10 days.

    The specific antibiotic used will depend on the type of bacteria causing your heart valve infection. The possible antibiotics include gentamicin, cefazolin, flucloxacillin, amoxicillin, ceftriaxone, or benzylpenicillin.

    During this phase, you will be admitted to the hospital for monitoring and treatment.

  2. Step 2

    Switch to oral antibiotics

    After the initial treatment phase, your treatment will be switched from intravenous to oral antibiotics, which means you will take the medication by mouth as tablets or capsules.

    The oral antibiotics that may be used include amoxicillin with clavulanic acid, amoxicillin, sulfamethoxazole with trimethoprim, moxifloxacin, clindamycin, rifampicin, or levofloxacin.

    The choice of antibiotic will be based on laboratory tests that identify which bacteria is causing your infection and which medications will work best against it.

  3. Step 3

    Blood sample collection for medication levels

    Blood samples will be taken at two different times during your oral antibiotic treatment.

    These blood samples will be used to measure the levels of antibiotic in your blood to ensure the medication is working effectively.

    This testing helps confirm that the amount of antibiotic in your body is sufficient to treat the infection.

  4. Step 4

    Completion of oral treatment

    You will continue taking oral antibiotics for the duration prescribed by your medical team.

    The total length of your antibiotic treatment will be determined based on your specific condition and response to therapy.

    At the end of your oral treatment period, you will be asked about your satisfaction with the treatment.

  5. Step 5

    Monitoring during treatment

    Throughout your entire treatment course, you will be monitored for any side effects from the antibiotics.

    Any complications, changes to your treatment, or issues with taking your medication will be recorded.

    The length of your hospital stay and total treatment duration will be tracked.

  6. Step 6

    Follow-up at six months

    Your health status will be assessed at 6 months after starting treatment.

    This assessment will check for any complications including recurrence of infection, need for unplanned heart surgery, blood clots traveling to other parts of the body, or return of bacteria in the bloodstream.

    This follow-up evaluation is the final step in assessing the success of your treatment.

Who can join the trial?

7 criteria

  • You or your legal representative must sign a written consent form before any screening tests are done
  • You must be at least 18 years old when you sign the consent form
  • If you are able to become pregnant, you must use highly effective birth control methods, which are ways to prevent pregnancy that work more than 99% of the time when used correctly. These include implants (small devices placed under the skin), injections (shots given regularly), birth control pills taken daily, certain IUDs (small devices placed in the uterus), not having sexual intercourse at all during the study treatment period, or having a partner who has had a vasectomy (a permanent procedure to prevent pregnancy)
  • You must have a confirmed diagnosis of infective endocarditis, which is an infection of the heart valves. This can affect either your natural heart valve or an artificial valve. The diagnosis must be confirmed by current medical standards, which include clinical examination, laboratory tests to identify germs, tissue samples if available, and imaging tests like ultrasound of the heart
  • If your case is classified as possible but not definite infective endocarditis, a team of specialists will review your case and decide if treatment is needed. If they decide to treat you, you can be included in the study
  • You must be admitted to the hospital during the first phase of treatment, which means you have received less than 10 days of intravenous treatment (medication given directly into your vein through a tube)
  • The germ causing your infection must be identified as one of the following types: Streptococcus, Enterococcus faecalis, Staphylococcus aureus, coagulase negative staphylococcus, or a gram negative bacteria. Laboratory tests showing which antibiotics can kill the germ must be available or in progress

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

Oral antibiotics are medications taken by mouth to fight bacterial infections. In this trial, patients with infective endocarditis (a heart infection) will switch from receiving antibiotics through an IV in their vein to taking antibiotic pills or liquids by mouth. This switch to oral antibiotics happens after the initial treatment period and is meant to complete the treatment at home instead of staying in the hospital.

What is already known about the treatment

Oral Antibiotic Therapy – This treatment involves taking antibiotics by mouth in pill or liquid form, rather than receiving them through an intravenous line in a vein. In the ROSIE trial, researchers are studying whether switching patients with infective endocarditis (a serious infection of the heart valves) from intravenous antibiotics to oral antibiotics partway through treatment works just as well as the standard approach. The antibiotics work by killing or stopping the growth of bacteria that cause the infection, with different types targeting specific parts of bacterial cells such as their walls, protein-making machinery, or genetic material. This approach could allow patients to complete their treatment at home instead of staying in the hospital for weeks, improving their quality of life while maintaining effective treatment of the heart infection.

Investigated diseases

Infective Endocarditis – Infective endocarditis is an infection of the inner lining of the heart chambers and heart valves. It occurs when bacteria or other germs enter the bloodstream and attach to damaged areas of the heart. The infection causes growths called vegetations to form on the heart valves, which consist of germs and blood clots. These vegetations can damage the heart valves and interfere with normal blood flow through the heart. Pieces of the vegetations may break off and travel through the bloodstream to other organs, causing additional problems. The condition typically develops over weeks to months, though it can sometimes progress more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524484-20-00Protocol codeS70926Estimated enrolment152 patientsSponsorUZ Leuven

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).