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;
Parallel
Dalbavancin administration
DrugA 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.
Standard antibiotic therapy
DrugStandard 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).
Cure rate
Clinical cure without relapse, defined by the absence of all the following: * Local and/or general signs of infection: * Relapse of bacteremia to S. aureus - i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials); * In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14; * In both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30; * Deep focus infection including endocarditis; * Death from all causes.
Cure rate
Clinical cure at DAY 14 and DAY 90 (EOS) defined by the absence of all the following: * For DAY 14 and DAY 90: a. Local and/or general signs of infection: i. local: redness, induration, swelling, purulent discharge; ii. general: fever, chills; b. Relapse of bacteremia to S. aureus - i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials); * Additional criteria at EOS only: c. Any additional antibiotic therapy active on S. aureus received between DAY 14 and DAY 90 (EOS);
Mortality rate
Death all-cause occurring within 90 days of follow-up.
Bloodstream clearance
Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14.
Patient's quality of life
Autonomy, pain and anxiety using 5-level EQ-5D scale
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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
