title: A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection.
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.
  
  
  BACKGROUND
  NCT02127970.
authors.affiliation: Allergan plc, Branford, Connecticut.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Dunne
authors.affiliation: Allergan plc, Branford, Connecticut.
authors.forename: Sailaja
authors.initials: S
authors.lastname: Puttagunta
authors.affiliation: Orlando Health, Florida.
authors.forename: Philip
authors.initials: P
authors.lastname: Giordano
authors.affiliation: Stradins University Hospital, Riga, Latvia.
authors.forename: Dainis
authors.initials: D
authors.lastname: Krievins
authors.affiliation: Allergan plc, Branford, Connecticut.
authors.forename: Michael
authors.initials: M
authors.lastname: Zelasky
authors.affiliation: Janssen Pharmaceuticals, Springhouse, Pennsylvania.
authors.forename: James
authors.initials: J
authors.lastname: Baldassarre
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus; D008875:Middle Aged; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D013203:Staphylococcal Infections / Q000188:drug therapy; D017334:Teicoplanin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D017334:Teicoplanin; C469289:dalbavancin
keywords: clinical trial; dalbavancin; efficacy; methicillin-resistant Staphylococcus aureus; skin infection