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Study Comparing Dalbavancin to Standard Antibiotics for Patients with Staphylococcus aureus Bloodstream Infections

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 is focused on studying infections in the bloodstream caused by a type of bacteria called Staphylococcus aureus. These infections are often related to the use of catheters, which are tubes inserted into the body to deliver or remove fluids. The study is comparing a single dose of a medication called Dalbavancin, given through an infusion, to the standard antibiotic treatments that are usually given for 14 days. The goal is to see if Dalbavancin is as effective as the standard treatments in curing the infection without it coming back.

Participants in the study will receive either the single dose of Dalbavancin or the standard antibiotics. The study will monitor the participants for 30 days to check for signs of infection and ensure the infection does not return. The study will also look at other factors such as the time it takes for the infection to clear from the blood, the duration of hospital stays, and any side effects experienced by the participants.

The study aims to provide valuable information on whether a single dose of Dalbavancin can be a simpler and effective alternative to the longer standard antibiotic treatments for catheter-related bloodstream infections caused by Staphylococcus aureus. This could potentially lead to shorter treatment times and fewer hospital visits for patients in the future.

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

    Joining the study

    Upon joining the study, the patient is required to provide informed consent, confirming understanding and agreement to participate in the trial.

    Eligibility is confirmed based on criteria such as age (at least 18 years) and a positive blood culture for Staphylococcus aureus obtained within 96 hours before randomization.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: the dalbavancin group or the standard antibiotic therapy group.

    Randomization ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment administration

    For the dalbavancin group, a single dose of 1500 mg is administered intravenously.

    For the standard therapy group, antibiotics are administered according to national guidelines for a duration of 14 days.

  4. Step 4

    Monitoring and follow-up

    The patient is monitored for clinical cure without relapse at Day 30, which includes checking for the absence of infection signs and relapse of bacteremia.

    Additional follow-up visits are scheduled at Day 14 and Day 90 to assess clinical cure, autonomy, pain, and anxiety using the EQ-5D-5L scale.

  5. Step 5

    End of study

    The study concludes with an evaluation of the primary and secondary endpoints, including the duration of hospitalization and any adverse events experienced.

    The final assessment occurs at Day 90, marking the end of the study period for the patient.

Who can join the trial?

7 criteria

  • Patients must be at least 18 years old.
  • The first blood test must show a positive result for Staphylococcus aureus within 96 hours before joining the study. This means the bacteria was found in the blood sample taken within this time frame.
  • The patient must have a catheter-related bloodstream infection (CR-BSI). This is an infection linked to a tube used to give treatments directly into the bloodstream. It is confirmed by:
    • One positive blood test and signs of infection at the catheter site, or
    • At least one positive blood test from both the catheter and a vein, with a time difference of at least 2 hours between the two tests, and the same type of bacteria found in both tests, or
    • One positive blood test and a strong belief by the doctor that the infection is related to the catheter.
    • The intravascular catheter, which is a device like a port-a-cath or Piccline used to access veins, must be removed before joining the study.
    • The patient must sign a form agreeing to participate in the study, showing they understand what it involves.

Who cannot join the trial?

8 criteria

  • Patients with **complicated** infections. A complicated infection is one that is more severe or has spread to other parts of the body.
  • Patients who are **allergic** to the study medication or similar medications. An allergy is when your body reacts badly to something, causing symptoms like rash or difficulty breathing.
  • Patients who have **kidney** or **liver** problems. These are important organs that help filter and clean your blood.
  • Patients who are **pregnant** or **breastfeeding**. This is to ensure the safety of both the mother and the baby.
  • Patients who are participating in another clinical trial. This is to avoid any interference with the results of the study.
  • Patients who have a history of **substance abuse**. This means having problems with drugs or alcohol that could affect the study.
  • Patients with **immune system** disorders. The immune system is what helps your body fight off infections.
  • Patients who have received another **antibiotic** treatment recently. Antibiotics are medicines that help fight infections caused by bacteria.
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Investigated drugs

  • Dalbavancin

    is an antibiotic given as a single intravenous dose. It is being tested to see if it is as effective as the usual antibiotic treatments for infections related to catheters caused by Staphylococcus aureus. The goal is to determine if this single-dose treatment can work as well as the standard therapy over a 30-day period.

  • Standard Antibiotic Therapy

    refers to the usual treatment given for catheter-related bloodstream infections caused by Staphylococcus aureus. This involves taking antibiotics according to national guidelines for a period of 14 days. The trial is comparing this standard approach to the single-dose treatment with Dalbavancin.

What is already known about the treatment

Dalbavancin – Dalbavancin is administered as a single-dose intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating catheter-related bloodstream infections caused by Staphylococcus aureus. The main therapeutic indication is for infections related to catheters, specifically those caused by this type of bacteria. At the molecular level, Dalbavancin works by inhibiting the synthesis of bacterial cell walls, which is essential for bacterial growth and survival. It belongs to the pharmacological class of glycopeptide antibiotics.

Investigated diseases

Catheter-related bloodstream infections due to Staphylococcus aureus – This condition occurs when bacteria, specifically Staphylococcus aureus, enter the bloodstream through a catheter. It typically begins with local signs of infection at the catheter site, such as redness, swelling, or pus. As the infection progresses, it can lead to more general symptoms like fever, chills, and fatigue. If not addressed, the bacteria can spread, potentially causing complications in other parts of the body. The infection is often identified through blood cultures that detect the presence of the bacteria. Management of the condition involves addressing the source of the infection and monitoring for any signs of relapse.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514952-34-00Protocol codeAPHP220763Estimated enrolment406 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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