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Compares treatment options for Catheter Bacteremia
Official title Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
ClinicalTrials.gov ID: NCT05117398
What this study is testing
What is Dalbavancin administration?
Dalbavancin administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for catheter bacteremia.
Also referred to as Xydalba® administration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of the study is 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Thrombophlebitis;
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Garches, France
- Périgueux, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, France; Périgueux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.