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Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheterrelated bloodstream infections due to Staphylococcus aureus [DALICATH]
EU CTIS ID: 2024-514952-34-00
What this study is testing
To demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged at least 18 years
- First blood culture positive for S. aureus, obtained within 96 hours before randomization (the date considered is the date of the sampling, not the results)
- CR-BSI, defined as: o One positive blood culture AND Local signs of infection at the catheter site OR o at least one positive blood culture obtained from the catheter and the peripheral vein, AND o A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND o Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR o One positive blood culture AND o 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
You likely can't join if
- Polymicrobial BSI (Bloodstream infection)
- Severe liver disease (Child-Pugh C)
- Severely immunocompromised patients: o Neutropenia (< 500 neutrophils/µL) at randomization; o Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period; o Solid organ transplant;
- Contraindication to dalbavancin and/or glycopeptid
- Life expectancy < 3 months
- Active injection drug user
See the full eligibility criteria
- Patients aged at least 18 years
- First blood culture positive for S. aureus, obtained within 96 hours before randomization (the date considered is the date of the sampling, not the results)
- CR-BSI, defined as: o One positive blood culture AND Local signs of infection at the catheter site OR o at least one positive blood culture obtained from the catheter and the peripheral vein, AND o A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND o Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR o One positive blood culture AND o 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
- Polymicrobial BSI (Bloodstream infection)
- Severe liver disease (Child-Pugh C)
- Severely immunocompromised patients: o Neutropenia (< 500 neutrophils/µL) at randomization; o Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period; o Solid organ transplant;
- Contraindication to dalbavancin and/or glycopeptid
- 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 on antibiotic treatment (participation in another interventional trial not involving antibiotic treatment may be authorized after verification of the absence of interference between the two trials in terms of safety and methodology);
- Persons held in an institution by legal or official order, Patients under legal protection, Patients under guardianship or curatorship;
- Patients unable to give a free and informed consent
- Dalbavancin resistant strain (A strain sensitive to vancomycin or methicillin (by culture or molecular method) is considered sensitive to dalbavancin)
- Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.
- More than 96 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization
- Patient with known valvulopathy at risk of endocarditis according to the clinician, 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 clinical or clinically significant
- Failure to remove any intravascular catheter which was present when first positive blood culture
- Signs of infection associated with qSOFA 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.