Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus (DALICATH)
Catheter Bacteremia, Staphylococcus Aureus Infection
About this trial
This is an interventional treatment trial for Catheter Bacteremia focused on measuring catheter-related bloodstream infections, Staphylococcus aureus infection
Eligibility 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;
- Intravascular catheter - implantable venous access device - removed before randomization;
- Informed consent form date and signed by the patient.
Exclusion Criteria:
- Polymicrobial infection
- 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
- 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 within the previous three months or ongoing;
- Persons held in an institution by legal or official order;
- 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.
Sites / Locations
- Infectious Diseases Department, Raymond-Poincaré Hospital - APHP
- Infectious Diseases Department, CH PERIGUEUXRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dalbavancin
Standard documented antibiotic therapy for 14 days according to national guidelines.
Dalbavancin (Xydalba®) 1500 mg - One unique dose
As currently recommended, investigators will be encouraged to use the intravenous route for the entire duration of treatment. However, in order to interfere as little as possible with usual practice in each center, the antimicrobial therapy will be let to the choice of the physician in charge of the patient after a minimum of 7 days of intravenous treatment. During all the duration of the study, in case of worsening of the clinical condition requiring the prescription of antistaphylococcal, the clinician will prescribe additional antibiotherapy according to standard good practice.