NIH Study Finds Two-Dose Treatment Effective for Dangerous S. aureus Bacteremia

In the United States, 20,000 deaths were reported due to Staphylococcus aureus (S. aureus) that led to bloodstream infections (bacteremia). Standard treatment typically involves a peripherally inserted central catheter (PICC) for weeks with continuous intravenous (IV) antibiotic therapy. The complications include blood clots and secondary infections associated with PICC lines, which limit the activities. The drug dalbavancin is given with two quick IV infusions via a temporary catheter to increase patient convenience. 

Two IV doses of dalbavancin, spaced 7 days apart, are effective as 4 to 6 weeks of daily IV conventional antibiotic agents. This therapy is used for complicated S. aureus bacteremia. The findings come from a Phase 2b DOTS clinical trial funded by the National Institutes of Health (NIH). These study findings, published in the Journal of the American Medical Association, offer the clearest evidence for dalbavancin’s efficacy and safety in this clinical setting. This trial was led by Thomas L.Holland, Duke University School of Medicine, through NIH’s Antibacterial Resistance Leadership Group. 

A total of 200 adults were hospitalized with complicated S. aureus bacteremia from U.S. and Canadian medical centers. All patients were enrolled between 2021 and 2023, and received 3 to 10 days of initial broad-spectrum antibiotics. Before randomization, they had no detectable S. aureus in blood cultures. Participants were randomized to either 1500mg IV dalbavancin on days one and eight or standard therapy for 4 to 8 weeks. The standard therapy included daptomycin or vancomycin for methicillin-resistant S. aureus (MRSA), cefazolin, and anti-staphylococcal penicillin for methicillin-susceptible cases. 

The study outcomes included health-related quality of life, clinical infectious, and safety complications as well as mortality. All these endpoints were measured by an independent, blinded expert panel for 70 days. Also, comparing clinical effectiveness and safety among participants.

The clinical trials results showed a 47.7% probability that dalbavancin-treated patients experienced better overall clinical endpoints compared to those who received standard treatment. Clinical safety and efficacy profiles were comparable among participants. Additionally, discontinuation of therapy and catheter-related complications were more commonly observed in the participants of the standard therapy group. However, these differences did not significantly impact the overall clinical outcomes. Quality of life scores were similar between the two groups, possibly reflecting limitations in the survey tool and the minimal impact of the delivery method on patient experience. 

John Beigel, National Institute of Allergy and Infectious Diseases (NIAID), said that the limited antimicrobial therapies are experiencing increasing resistance in treatment. The establishment of dalbavancin as a feasible treatment option offers a vital new alternative therapy for complicated S. aureus bacteremia. 

Nicholas A. Turner, Duke University School of Medicine, stated that data findings provide clinical evidence to clinicians and patients to support an additional treatment option for complicated S. aureus bacteremia.

Reference: National Institutes of Health (NIH). Two-dose therapy for S. aureus bloodstream infections on par with standard treatment. 2025.  Two-dose therapy for S. aureus bloodstream infections on par with standard treatment | National Institutes of Health (NIH)

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