Actively Recruiting
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-06
406
Participants Needed
2
Research Sites
169 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
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).
CONDITIONS
Official 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 defined by positive blood cultures and local signs or strong clinical suspicion
- Intravascular catheter or implantable venous access device removed before randomization
- Signed informed consent form
You will not qualify if you...
- Polymicrobial infection
- Dalbavancin resistant 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 such as arthritis, pneumonia, osteomyelitis, or meningitis
- Thrombophlebitis
- Failure to remove any intravascular catheter present at first positive blood culture
- Signs of infection with quick SOFA score 2 or higher at randomization
- Presence of foreign bodies like prosthetic heart valve, endovascular prosthesis, shunts, pacemaker, or defibrillator
- Severe liver disease (Child-Pugh C)
- Severe immunocompromised state including neutropenia, recent or planned 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
- Premenopausal women not using highly-effective contraception for 1 month after study drug
- Participation in other ongoing interventional trials
- Persons held in legal or official institutions
- Patients under legal protection, guardianship, or curatorship
- Unable to give free and informed consent
- Not affiliated with a social security scheme or beneficiary thereof
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Aurélien DINH, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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