title: Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study.
abstract: BACKGROUND
  Oritavancin is a lipoglycopeptide antibiotic with rapid bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and long half-life allow for single-dose treatment.
  
  
  METHODS
  In a randomized, double-blind trial, adults with acute bacterial skin and skin structure infections (ABSSSIs) received either a single intravenous 1200-mg dose of oritavancin or 7-10 days of twice-daily vancomycin. Three efficacy endpoints were tested for noninferiority: (1) primary composite endpoint at 48-72 hours (cessation of spreading or reduction in lesion size, absence of fever, and no rescue antibiotic); (2) investigator-assessed clinical cure 7-14 days after end of treatment; and (3) ≥20% reduction in lesion area at 48-72 hours.
  
  
  RESULTS
  A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin, respectively. All 3 efficacy endpoints met the 10% noninferiority margin: the primary composite endpoint (80.1% vs 82.9%; 95% confidence interval [CI], -7.5 to 2.0), investigator-assessed clinical cure (82.7% vs 80.5%; 95% CI, -2.6 to 7.0), and proportion of patients attaining ≥20% reduction in lesion area (85.9% vs 85.3%; 95% CI, -3.7 to 5.0) for oritavancin vs vancomycin, respectively. Efficacy outcomes by pathogen, including methicillin-resistant Staphylococcus aureus and the frequency of adverse events, were similar between treatment groups.
  
  
  CONCLUSIONS
  A single 1200-mg dose of oritavancin was noninferior to 7-10 days of vancomycin in treating ABSSSIs caused by gram-positive pathogens, and was well tolerated. Oritavancin provides a single-dose alternative to multidose therapies for the treatment of ABSSSIs. Clinical Trials Registration. NCT01252732.
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Samantha
authors.initials: S
authors.lastname: Good
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Hai
authors.initials: H
authors.lastname: Jiang
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Greg
authors.initials: G
authors.lastname: Moeck
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Matthew
authors.initials: M
authors.lastname: Wikler
authors.affiliation: Sharp Grossmont Hospital, San Diego.
authors.forename: Sinikka
authors.initials: S
authors.lastname: Green
authors.affiliation: Paradise Valley Hospital, Oceanside.
authors.forename: Paul
authors.initials: P
authors.lastname: Manos
authors.affiliation: Physician Alliance Research Center, Anaheim, California.
authors.forename: Richard
authors.initials: R
authors.lastname: Keech
authors.affiliation: Government Medical College, Nagpur, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Singh
authors.affiliation: Novo Research, Long Beach, California.
authors.forename: Barry
authors.initials: B
authors.lastname: Heller
authors.affiliation: St George the Martyr City Hospital, St Petersburg, Russia.
authors.forename: Natalia
authors.initials: N
authors.lastname: Bubnova
authors.affiliation: Sharp Chula Vista Medical Center, California.
authors.forename: William
authors.initials: W
authors.lastname: O'Riordan
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006020:Glycopeptides / Q000627:therapeutic use*; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077427:Lipoglycopeptides; D008297:Male; D008875:Middle Aged; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D018461:Soft Tissue Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use* / Q000031:analogs & derivatives; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D006020:Glycopeptides; D000077427:Lipoglycopeptides; D014640:Vancomycin; C100708:oritavancin
keywords: acute bacterial skin and skin structure infection (ABSSSI); lipoglycopeptide; methicillin-resistant Staphylococcus aureus (MRSA); oritavancin; vancomycin