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