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RECRUITING

NCT05117398

PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2023-06-23

Completion Date

2026-09-23

Last Updated

2025-04-06

Healthy Volunteers

Conditions

Catheter Bacteremia Staphylococcus Aureus Infection

Interventions

DRUG

Dalbavancin administration

A single-dose of intraveneuse (IV) administration of dalbavancin of 1500 mg. In case of patients with chronic renal impairment (creatinin clairance \< 30mL/min), a single-dose of IV administration of reduced dalbavancin of 1000 mg.

DRUG

Standard antibiotic therapy

Standard Antibiotic therapy according to national recommendations. During the study, the start of treatment is considered to be the day of inclusion/randomization (even if active antiobiotic treatment was started, less than 72 hours ago according to inclusion criteria).

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.

Locations (2)

Infectious Diseases Department, Raymond-Poincaré Hospital - APHP

Garches, France

Infectious Diseases Department, CH PERIGUEUX

Périgueux, France