Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

APHP220763

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).

2023-06-23

2025-09-23

2026-09-23

Recruiting

Early phase I

406

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 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 interventional 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase III, pragmatic, open-label, non-inferiority, randomized (1:1), multicenter trial, in patients with non-complicated CR-BSI due to S. aureus, with two parallel groups receiving 14 days of active antimicrobial therapy.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 406, 'type': 'ESTIMATED'}}

2023-09-05