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Study on Continuous vs. Intermittent Infusion of Ampicillin and Ceftriaxone for Patients with Enterococcus faecalis Infective Endocarditis

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What is this trial about?

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

This clinical trial is focused on studying the treatment of Enterococcus faecalis infective endocarditis, a serious infection of the heart's inner lining caused by the bacteria Enterococcus faecalis. The study will compare two methods of administering antibiotics: continuous infusion and intermittent infusion. The antibiotics being tested are ampicillin and ceftriaxone. Ampicillin is a type of penicillin antibiotic, while ceftriaxone is a cephalosporin antibiotic. Both are commonly used to treat bacterial infections.

The purpose of the study is to determine if continuous infusion of these antibiotics is as effective as intermittent infusion in treating the infection. Participants in the study will receive either the continuous or intermittent infusion of the antibiotics. The study will monitor the frequency of disease recurrence, which means checking if the infection comes back after treatment. The study will also look at other factors, such as the need for changes in antibiotic treatment, unplanned surgeries, and any side effects related to the medication.

The study will last for a period of up to 42 days of treatment, with follow-up assessments to check for any recurrence of the infection or other health issues. Participants will be monitored for up to one year after completing the antibiotic treatment to ensure the infection does not return and to assess overall health outcomes. The study aims to provide valuable information on the best way to administer these antibiotics for treating Enterococcus faecalis infective endocarditis.

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, eligibility is confirmed based on age (18 years or older) and a diagnosis of infective endocarditis caused by Enterococcus faecalis.

    Informed consent is required to participate in the study.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of two antibiotics: ampicillin and ceftriaxone.

    These medications are given through an intravenous route, which means they are delivered directly into the bloodstream.

  3. Step 3

    Treatment administration

    The study compares two methods of administering the antibiotics: continuous infusion and intermittent infusion.

    Continuous infusion involves a steady and constant delivery of medication, while intermittent infusion involves administering the medication at intervals.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the effectiveness of the treatment is monitored by checking for any recurrence of the infection.

    The primary goal is to ensure that the continuous infusion method is not less effective than the intermittent method.

  5. Step 5

    Evaluation of outcomes

    The study evaluates several outcomes, including treatment failure, mortality, and any need for changes in antibiotic treatment.

    Other factors assessed include unplanned surgeries, readmissions, and any adverse effects related to the medication.

  6. Step 6

    Completion of treatment

    The treatment period lasts for six weeks, after which the patient's health is monitored for up to one year to check for any recurrence of the infection.

    The study aims to gather data on the long-term effectiveness and safety of the treatment methods.

Who can join the trial?

3 criteria

  • Adult patients who are **18 years of age or older**.
  • Patients with a **possible or definitive diagnosis** of infective endocarditis due to **Enterococcus faecalis**. This diagnosis should be made according to the **Duke-ISCVID criteria**, which are guidelines used by doctors to identify this type of heart infection.
  • Patients must have **signed informed consent**, meaning they agree to participate in the study after being informed about what it involves.

Who cannot join the trial?

5 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have medical conditions or factors that the study has not specifically mentioned as being included.
  • Patients who are unable to follow the study procedures or take the study medications as required.
  • Patients who have other health issues that could interfere with the study or make it unsafe for them to participate.
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Investigated drugs

  • Ampicillin

    is an antibiotic used to treat a variety of bacterial infections. In this clinical trial, it is being tested to see if it can effectively treat Enterococcus faecalis infective endocarditis when given continuously, as opposed to intermittently. The goal is to determine if continuous infusion is as effective as the traditional method of administering the medication.

  • Ceftriaxone

    is another antibiotic that is often used in combination with other antibiotics to treat serious infections. In this study, it is paired with ampicillin to evaluate its effectiveness in treating Enterococcus faecalis infective endocarditis. The trial is comparing the outcomes of continuous infusion versus intermittent infusion to see if there is a difference in the recurrence of the disease.

What is already known about the treatment

  • Ampicillin

    Ampicillin is administered intravenously, either through continuous or intermittent infusion. It is currently used in clinical trials to treat Enterococcus faecalis infective endocarditis. The main therapeutic indication is for bacterial infections, particularly those caused by Enterococcus species. Ampicillin works by inhibiting bacterial cell wall synthesis, leading to cell death. It is classified as a beta-lactam antibiotic.

  • Ceftriaxone

    Ceftriaxone is given intravenously, either as a continuous or intermittent infusion. It is being studied in clinical trials for its effectiveness in treating Enterococcus faecalis infective endocarditis. The primary therapeutic use is for treating bacterial infections, including those caused by Enterococcus. Ceftriaxone acts by disrupting bacterial cell wall formation, resulting in bacterial cell death. It belongs to the class of cephalosporin antibiotics.

Investigated diseases

Enterococcus faecalis infectious endocarditis – This disease is an infection of the inner lining of the heart chambers and valves, caused by the bacterium Enterococcus faecalis. It typically occurs when bacteria enter the bloodstream and attach to damaged areas of the heart. The infection can lead to inflammation and damage to the heart valves, potentially causing them to malfunction. Symptoms may include fever, fatigue, heart murmurs, and signs of heart failure. The disease progresses as the bacteria continue to grow and form clumps, which can break off and travel to other parts of the body, causing further complications. If not managed, it can lead to severe heart damage and other systemic issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511719-40-00Protocol codeDOβLEIEstimated enrolment284 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

sourced from the EU Clinical Trials Register and site verification

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