Comparing dalbavancin to standard antibiotics for bloodstream infections from Staphylococcus aureus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a single dose of intravenous dalbavancin compared to standard antibiotic therapy for treating catheter-related bloodstream infections (CR-BSIs) caused by Staphylococcus aureus. The primary objective is to demonstrate that dalbavancin is non-inferior to the standard treatment over a 30-day follow-up period. Secondary objectives include assessing cure rates, mortality rates, time to negative blood cultures, quality of life, length of hospital stay, cost-utility, and adverse events. The study targets patients with uncomplicated CR-BSIs who have had their infected catheters removed prior to randomization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged at least 18 years;
* Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);
* CR-BSI, defined as:

  * One positive blood culture AND Local signs of infection at the catheter site; OR
  * at least one positive blood culture obtained from the catheter and the peripheral vein; AND
  * A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND
  * Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR
  * One positive blood culture; AND
  * Strong presumption of catheter-related infection according to clinical opinion.
* Intravascular catheter - implantable venous access device (port-a-cath and Piccline) - removed before randomization;
* Informed consent form date and signed by the patient.

Exclusion Criteria:

* Polymicrobial infection;
* Dalbavancin resistant strain;
* More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;
* Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;
* Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);
* Thrombophlebitis;
* Failure to remove any intravascular catheter which was present when first positive blood culture;
* Signs of infection associated with quick SOFA score ≥ 2 at randomization;
* Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device;
* Severe liver disease (Child-Pugh C);
* Severely immunocompromised patients:

  * Neutropenia (\< 500 neutrophils/µL) at randomization;
  * Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period;
  * Solid organ transplant;
* Contraindication to dalbavancin and/or glycopeptide;
* Life expectancy \< 3 months;
* Active injection drug user;
* Pregnant or breastfeeding women;
* For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug;
* Participation in other interventional trials ongoing;
* Persons held in an institution by legal or official order;
* Patients under legal protection;
* Patients under guardianship or curators;
* Patients unable to give a free and informed consent;
* Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.

Where it's running

• Infectious Diseases Department, CH PERIGUEUX
  Périgueux, France Recruiting
• Infectious Diseases Department, Raymond-Poincaré Hospital - APHP
  Garches, France Not yet recruiting

Study contacts

• Principal investigator: Bernard CASTAN, MD — CH de Perigueux
• Study coordinator: Bernard CASTAN, MD
• Email: bernard.castan@ch-perigueux.fr
• Phone: +33 5 53 45 26 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using clindamycin to improve treatment of skin infections caused by Staphylococcus aureus

  This study is testing if adding clindamycin to regular treatment can help adults in Sierra Leone recover faster from skin infections caused by Staphylococcus aureus.

  Recruiting Phase 4 Universität Münster · Masokori · NCT05899140

• Switching to dabigatran versus staying on apixaban/edoxaban/rivaroxaban for S. aureus bloodstream infection

  This trial will try whether switching people with S. aureus bloodstream infection who are already taking apixaban, edoxaban, or rivaroxaban to dabigatran leads to better outcomes.

  Recruiting at 3 sites Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · St. John's, Newfoundland and Labrador and 2 other locations · NCT06650501

• Clopidogrel versus aspirin to lower cardiovascular and infection complications in people with Staphylococcus aureus bloodstream infection

  This will try switching people with Staphylococcus aureus bloodstream infection who are already taking aspirin for heart protection to clopidogrel to see if it improves infection outcomes.

  Recruiting at 3 sites Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · St. John's, Newfoundland and Labrador and 2 other locations · NCT06650488

• Comparing two antibiotics for treating Staphylococcus aureus bloodstream infections

  This study is testing whether benzylpenicillin works better than cloxacillin for treating bloodstream infections caused by Staphylococcus aureus in adults.

  Recruiting Phase 4 Region Skane · Lund · NCT06726395

• Combination Antibiotics for Staphylococcus aureus Bacteremia in adults

  This study tests whether using two antibiotics together for adults with Staphylococcus aureus in the blood works better than a single antibiotic.

  Recruiting at 13 sites Phase 4 Intermountain Health Care, Inc. · Brighton, Colorado and 12 other locations · NCT07376889

• Comparing Daptomycin and Vancomycin for MRSA Bloodstream Infections

  This study is testing whether daptomycin or vancomycin works better for treating bloodstream infections caused by MRSA in patients.

  Recruiting at 20 sites Phase 4 McGill University Health Centre/Research Institute of the McGill University Health Centre · Blacktown, New South Wales and 19 other locations · NCT06637332

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.