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Study on Shortened Antibiotic Treatment for Infectious Endocarditis Using Vancomycin, Meropenem, and Ceftriaxone for Patients with Left-Sided Heart Infection

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 clinical trial focuses on the treatment of infectious endocarditis, a serious infection of the heart's inner lining, often affecting the heart valves. The study aims to evaluate the safety and effectiveness of a shorter course of antibiotic treatment for this condition. Specifically, it targets infections caused by the bacteria Staphylococcus aureus, Enterococcus faecalis, or streptococci. The antibiotics being studied include Vancomycin, Meropenem, Ceftriaxone, Benzylpenicillin, Ampicillin, Cloxacillin, Cefotaxime, and Daptomycin. These medications are administered intravenously, meaning they are given directly into a vein.

The purpose of the study is to determine if a shorter treatment duration is as safe and effective as the standard longer treatment. Participants will receive one of the antibiotics or a combination, and some may receive a placebo. The study will monitor participants for six months to observe any outcomes such as death, septic embolization (a condition where infected particles travel through the bloodstream and block blood vessels), recurrence of the infection, or the need for heart surgery. Additionally, the study will look at hospital-related expenses, the length of hospital stay, the duration of antibiotic treatment, and any complications related to the intravenous administration of the drugs.

Participants will be closely monitored throughout the study period, which will last up to six months. The study will help determine if a shorter course of antibiotics can effectively treat infectious endocarditis, potentially leading to shorter hospital stays and reduced healthcare costs. This research is important for improving treatment strategies and outcomes for patients with this serious heart infection.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures of the clinical trial. You will be asked to provide your consent to participate.

    The study focuses on the treatment of infectious endocarditis, specifically targeting infections caused by Staphylococcus aureus, Enterococcus faecalis, or streptococci.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have left-sided endocarditis and are infected with one of the specified bacteria.

    Your medical history and current health status will be reviewed to ensure you meet the study criteria.

  3. Step 3

    Treatment phase

    You will receive a course of antibiotic treatment administered intravenously. The specific medication and dosage will depend on your condition and the bacteria causing the infection.

    The medications used in the study include vancomycin, meropenem trihydrate, ceftriaxone sodium, benzylpenicillin sodium, ampicillin, cloxacillin sodium, cefotaxime, and daptomycin.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment, your health will be closely monitored. This includes regular check-ups and tests to assess the effectiveness of the treatment and any side effects.

    You will be observed for any signs of improvement or complications related to the treatment.

  5. Step 5

    End of treatment

    The treatment phase will conclude once the prescribed course of antibiotics is completed. The duration of the treatment will be determined by your response to the medication.

    A final assessment will be conducted to evaluate the outcome of the treatment and your overall health status.

  6. Step 6

    Post-treatment follow-up

    After the treatment ends, you will continue to be monitored for up to six months. This is to track any long-term effects or recurrence of the infection.

    The primary outcomes being monitored include death, septic embolization, recurrence of the infection, and any unplanned heart surgery.

Who can join the trial?

5 criteria

  • Must be over 18 years old.
  • Must be staying in a hospital ward.
  • Must have left-sided endocarditis according to the modified Duke's criteria. Endocarditis is an infection of the inner lining of the heart chambers and valves.
  • Must have an infection caused by one of the following bacteria: Staphylococcus aureus, streptococci, or Enterococcus faecalis. These are types of bacteria that can cause infections.
  • Must have given informed consent, meaning you agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

  • Patients with **infectious endocarditis** caused by bacteria other than **Staphylococcus aureus**, **Enterococcus faecalis**, or **streptococci** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Antibiotics are the main type of medication used in this clinical trial. They are drugs that help fight infections caused by bacteria. In this study, the antibiotics are used to treat a serious heart infection called infectious endocarditis. The goal is to see if a shorter course of these antibiotics can be just as safe and effective as the longer treatments usually given. The trial focuses on infections caused by specific bacteria, including Staphylococcus aureus, Enterococcus faecalis, and streptococci. By using antibiotics, the study aims to kill the bacteria causing the infection and help patients recover more quickly.

What is already known about the treatment

Antibiotic Treatment for Infectious Endocarditis – This medication is administered orally or intravenously, depending on the specific antibiotic used and the severity of the infection. It is currently being studied in clinical trials to determine the safety and effectiveness of a shorter treatment course for infectious endocarditis, particularly for infections on the left side of the heart caused by bacteria such as Staphylococcus aureus, Enterococcus faecalis, or streptococci. The main therapeutic use of this medication is to treat infectious endocarditis, a serious infection of the heart's inner lining. At the molecular level, antibiotics work by targeting and killing bacteria or stopping their growth, which helps the body's immune system to clear the infection. This medication falls under the pharmacological classification of antibiotics, which are drugs used to treat bacterial infections.

Investigated diseases

Infectious endocarditis – Infectious endocarditis is an infection of the inner lining of the heart chambers and valves, typically caused by bacteria. The disease begins when bacteria enter the bloodstream and attach to damaged areas of the heart. As the infection progresses, it can lead to the formation of clumps of bacteria and cells, known as vegetations, on the heart valves. These vegetations can cause damage to the heart valves, leading to heart dysfunction. The disease may also result in the spread of infection to other parts of the body, causing complications such as septic embolization. Over time, the heart's ability to function properly can be compromised, leading to further health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507652-76-00Estimated enrolment50 patientsSponsorRegion Skane

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