DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2b clinical study, multicenter, randomized, open-label, assessor-blinded,
superiority study. The study will compare dalbavancin to standard of care antibiotic therapy
for the completion of therapy in patients with complicated bacteremia or right-sided native
valve Infective Endocarditis (IE) caused by S. aureus who have cleared their baseline
bacteremia. Approximately 200 subjects will be randomized 1:1 to receive either dalbavancin
or a standard of care antibiotic regimen that is based upon the identification and antibiotic
susceptibility pattern of the baseline organism. Subjects randomized to the dalbavancin
treatment group will receive 2 doses of dalbavancin intravenously (IV) 1 week apart (1500 mg
on Day 1 and Day 8 after randomization, with renal dose adjustment if appropriate). Subjects
randomized to the standard of care antibiotic therapy treatment group will receive an
antibiotic regimen considered to be standard of care based on the methicillin susceptibility
pattern of the pathogen isolated at baseline for a duration of 4 to 6 weeks and up to 8 weeks
for patients with vertebral osteomyelitis/discitis. The primary objective is to compare the
Desirability of Outcome Ranking (DOOR) at Day 70 of dalbavancin to that of standard of care
antibiotic therapy used to consolidate therapy for the treatment of subjects with complicated
S. aureus bacteremia in the intent-to-treat population (ITT).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)