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);
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
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;
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Centre Hospitalier de Perigueux
Collaborator
Advanz Pharma
Collaborator
Nantes University Hospital
Collaborator
Centre National de Référence des staphylocoques
Collaborator