Actively Recruiting
Randomized Trial Comparing Single-dose Intravenous Dalbavancin Versus Standard 14-day Antibiotic Therapy for Staphylococcus Aureus Catheter-related Bloodstream Infections
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06
406
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
C
Centre Hospitalier de Perigueux
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for catheter-related bloodstream infections (CR-BSIs) caused by Staphylococcus aureus, a common and serious hospital infection. This study aims to demonstrate that a single intravenous dose of dalbavancin is not less effective than the standard 14-day antibiotic treatment following catheter removal. The research also looks at cure rates at different times, mortality within 90 days, time to clear blood infection, patient quality of life, hospital stay length, costs, and adverse events. Participants will receive either a single 1500 mg intravenous dose of dalbavancin or the standard antibiotic therapy recommended by national guidelines for 14 days, which may include an oral switch after at least 7 days of intravenous treatment. Dalbavancin's long half-life allows effective treatment with one dose, potentially reducing hospital stays and catheter-related complications. In case of clinical worsening, additional antibiotics may be prescribed as needed. During the study, patients will be closely monitored with blood cultures, assessments of infection clearance, quality of life questionnaires, and evaluations of hospital stay duration and healthcare costs. Adverse events will be tracked until 90 days after treatment. The main measure of success is the cure rate at 30 days. Participation includes follow-up visits up to 90 days to assess outcomes and safety, with total involvement lasting about three months.
CONDITIONS
Brief Title
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged at least 18 years
- Blood cultures positive for Staphylococcus aureus obtained within 72 hours before randomization
- Catheter-related bloodstream infection confirmed by specific blood culture criteria or strong clinical suspicion
- Intravascular catheter (including port-a-cath and Piccline) removed before randomization
- Signed informed consent form by the patient
You will not qualify if you...
- Polymicrobial infection
- Dalbavancin-resistant bacterial strain
- More than 72 hours of active antibiotic treatment targeting Staphylococcus aureus before randomization
- Known valvulopathy, previous endocarditis, or suspicion of infective endocarditis
- Suspicion of other deep infections like arthritis, pneumonia, osteomyelitis, or meningitis
- Presence of cerebral or peripheral emboli
- Thrombophlebitis
- Failure to remove any intravascular catheter present at first positive blood culture
- Signs of infection with quick SOFA score 2 at randomization
- Presence of foreign bodies such as prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or implantable cardioverter defibrillator
- Severe liver disease (Child-Pugh C)
- Severely immunocompromised status including neutropenia, recent or planned hematopoietic stem cell transplant, or solid organ transplant
- Contraindication to dalbavancin or glycopeptides
- Life expectancy less than 3 months
- Active injection drug use
- Pregnant or breastfeeding women
- For premenopausal women, failure to use highly-effective contraception for 1 month after study drug
- Participation in other ongoing interventional trials
- Persons held by legal or official order
- Patients under legal protection, guardianship, or curatorship
- Inability to give free and informed consent
- Not affiliated with a social security scheme or beneficiary required by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive either a single intravenous dose of dalbavancin after catheter removal or standard antibiotic therapy for 14 days according to national guidelines. Those in the standard therapy group may switch to oral antibiotics after at least 7 days of IV treatment based on physician's decision.
1 baseline visit and weekly visits during treatment
Duration - Up to 90 days
Participants are monitored for treatment effectiveness, safety, and quality of life up to 90 days after treatment starts.
Visits at Day 14, Day 30, and Day 90
Trial Site Locations
Total: 2 locations
1
Infectious Diseases Department, Raymond-Poincaré Hospital - APHP
Garches, France, 92380
Not Yet Recruiting
2
Infectious Diseases Department, CH PERIGUEUX
Périgueux, France, 24019
Actively Recruiting
Research Team
B
Bernard CASTAN, MD
A
Aurélien DINH, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here