Dalbavancin not superior to standard therapy, but met the noninferiority criterion
By Elana Gotkine HealthDay Reporter
FRIDAY, Aug. 15, 2025 (HealthDay News) — Dalbavancin is not superior to standard therapy for adults with complicated Staphylococcus aureus bacteremia, but clinical efficacy met the criteria for noninferiority, according to a study published online Aug. 13 in the Journal of the American Medical Association.
Nicholas A. Turner, M.D., from Duke University in Durham, North Carolina, and colleagues examined the efficacy and safety of dalbavancin versus standard therapy for completion of treatment of complicated S. aureus bacteremia in a randomized clinical trial conducted from April 2021 to December 2023 at 23 U.S. medical centers. Hospitalized adults with complicated S. aureus bacteremia who achieved blood culture clearance following at least 72 hours but no more than 10 days of initial antibacterial therapy were randomly assigned to receive two doses of intravenous dalbavancin on days 1 and 8 or four to eight weeks of standard intravenous therapy (cefazolin or an antistaphylococcal penicillin if methicillin-susceptible; vancomycin or daptomycin if methicillin-resistant).
Two hundred participants were randomly assigned (100 to each group), and of these, 167 survived to day 70 and underwent an efficacy assessment. The researchers found that the probability of a more desirable day 70 outcome was 47.7 percent with dalbavancin versus standard therapy, which did not meet the criterion for superiority. Clinical efficacy was documented in 73 of 100 for dalbavancin and 72 of 100 for standard therapy, meeting the criterion for noninferiority. Serious adverse events were reported in 40 and 34 participants, respectively, who received dalbavancin and standard therapy; in both groups, treatment-related adverse events were uncommon.
“Our findings give patients and health care providers the data to support an extra choice when deciding on treatment for complicated S. aureus bacteremia,” Turner said in a statement.
Several authors disclosed ties to the biopharmaceutical industry.
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