Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Mar 1;62(5):545-51.
doi: 10.1093/cid/civ982. Epub 2015 Nov 26.

A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection

Michael W Dunne  1 , Sailaja Puttagunta  1 , Philip Giordano  2 , Dainis Krievins  3 , Michael Zelasky  1 , James Baldassarre  4
Affiliations
Randomized Controlled Trial

A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection

Michael W Dunne et al. Clin Infect Dis. .

Abstract

Background: Acute bacterial skin and skin structure infections (ABSSSIs) are a cause of significant morbidity and therapy can be a burden to the healthcare system. New antibiotics that simplify treatment and avoid hospitalization are needed. This study compared the safety and efficacy of a single intravenous infusion of 1500 mg of dalbavancin to the 2-dose regimen.

Methods: This study was a randomized, double-blind trial in patients aged >18 years with ABSSSIs. Patients were randomized to dalbavancin 1500 mg either as a single intravenous (IV) infusion or 1000 mg IV on day 1 followed 1 week later by 500 mg IV. The primary endpoint was a ≥20% reduction in the area of erythema at 48-72 hours in the intent-to-treat population. Noninferiority was to be declared if the lower limit of the 95% confidence interval (CI) on the difference in the outcomes was greater than -10%. Clinical outcome was also assessed at days 14 and 28.

Results: Six hundred ninety-eight patients were randomized. Demographic characteristics were similar on each regimen, although there were more patients with methicillin-resistant Staphylococcus aureus (MRSA) at baseline on the 2-dose regimen (36/210 [17.1%] vs 61/220 [27.7%]). Dalbavancin delivered as a single dose was noninferior to a 2-dose regimen (81.4% vs 84.2%; difference, -2.9% [95% CI, -8.5% to 2.8%]). Clinical outcomes were also similar at day 14 (84.0% vs 84.8%), day 28 (84.5% vs 85.1%), and day 14 in clinically evaluable patients with MRSA in a baseline culture (92.9% vs 95.3%) in the single- and 2-dose regimens, respectively. Treatment-emergent adverse events occurred in 20.1% of the single-dose patients and 19.9% on the 2-dose regimen.

Conclusions: A single 1500-mg infusion of dalbavancin is noninferior to a 2-dose regimen, has a similar safety profile, and removes logistical constraints related to delivery of the second dose.

Clinical trials registration: NCT02127970.

Keywords: clinical trial; dalbavancin; efficacy; methicillin-resistant Staphylococcus aureus; skin infection.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Disposition of patients and analysis sets. Abbreviation: ITT, intent to treat.
See this image and copyright information in PMC

References

    1. Pallin DJ, Egan DJ, Pelletier AJ et al. . Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med 2008; 51:292–8. - PubMed
    1. David MZ, Medvedev S, Hohmann SF, Ewigman B, Daum RS. Increasing burden of methicillin-resistant Staphylococcus aureus hospitalizations at US academic medical centers, 2003–2008. Infect Control Hosp Epidemiol 2012; 33:782–9. - PMC - PubMed
    1. David MZ, Daum RS, Bayer AS et al. . Staphylococcus aureus bacteremia at five U.S. academic medical centers, 2008–2011: significant geographic variation in community-onset infections. Clin Infect Dis 2014; 15:798–807. - PMC - PubMed
    1. Liu C, Bayer A, Cosgrove SE et al. . Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011; 52:e18–55. - PubMed
    1. Daum RS. Clinical practice. Skin and soft-tissue infections caused by methicillin-resistant Staphylococcus aureus. N Engl J Med 2007; 357:380–90. - PubMed

Publication types

Associated data