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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Reseau De Sante Mutualiste Villeurbanne France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Jean Rougier Cahors France
Medipole Hopital Prive Villeurbanne France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier De Pau Pau France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
23.06.2023

Trial locations

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.

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 ID:
2024-514952-34-00
Protocol code:
APHP220763
NCT ID:
NCT05117398
Trial Phase:
Therapeutic confirmatory (Phase III)

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