RecruitingPhase 3

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

France406 participantsStarted 2023-06-23

Plain-language summary

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). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. Cost-utility analyses; 7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cure rate

Timeframe: DAY 30

Trial details

NCT IDNCT05117398

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-23

Contact for this trial

Bernard CASTAN, MD

+33 5 53 45 26 00 bernard.castan@ch-perigueux.fr

View on ClinicalTrials.gov More Catheter Bacteremia trials