The DOTS randomized clinical trial compared dalbavancin, a long-acting intravenous lipoglycopeptide, with standard intravenous therapy for the completion of treatment in adults with complicated Staphylococcus aureus bacteremia. Conducted at 23 medical centers in the US and Canada between April 2021 and December 2023, the trial enrolled 200 hospitalized adults who had achieved blood culture clearance after at least 72 hours of initial antibiotic therapy. Participants were randomized to either receive two doses of dalbavancin (days 1 and 8) or 4–8 weeks of standard therapy with cefazolin, antistaphylococcal penicillin, vancomycin, or daptomycin, depending on susceptibility. The primary endpoint was desirability of outcome ranking (DOOR) at day 70, which incorporated clinical success, complications, safety, mortality, and quality of life.
The results showed no superiority of dalbavancin over standard therapy, with the probability of a more desirable DOOR outcome being 47.7% (95% CI, 39.8%–55.7%). However, dalbavancin did achieve noninferiority for clinical efficacy, with 73% of patients demonstrating success compared to 72% in the standard therapy group (difference, 1.0%; 95% CI, −11.5% to 13.5%). Serious adverse events occurred in both groups at similar rates, and treatment-related adverse events were uncommon. These findings suggest that while dalbavancin does not outperform standard therapy in overall desirability, it may represent a practical alternative for completing therapy in complicated S. aureus bacteremia, particularly in situations where avoiding prolonged intravenous access is advantageous.
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