title: A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections.
abstract: BACKGROUND
  A randomized, double-blind, multicenter trial was done to compare two doses of delafloxacin with tigecycline in patients with various complicated skin and skin-structure infections (wound infections following surgery, trauma, burns, or animal/insect bites, abscesses, and cellulitis).
  
  
  METHODS
  Patients were randomized 1:1:1 to receive delafloxacin 300mg intravenous (IV) every 12h, delafloxacin 450mg IV every 12h, or tigecycline 100mg IV×1, followed by 50mg IV every 12h; randomization was stratified by infection type. Duration of therapy was 5-14 days. The primary efficacy analysis, performed on the clinically evaluable (CE) population at the test-of-cure (TOC) visit (14-21 days after the final dose of study drug), compared clinical response rates in the delafloxacin and tigecycline arms. Clinical response rates in the two delafloxacin arms were also compared.
  
  
  RESULTS
  Among CE patients, clinical cure rates at TOC visit were similar in the delafloxacin and tigecycline arms (94.3%, 92.5%, and 91.2%, respectively in delafloxacin 300-mg, delafloxacin 450-mg, and tigecycline arms). Overall, the most frequent adverse events were nausea, vomiting, and diarrhea; the 300-mg delafloxacin arm was the best-tolerated regimen.
  
  
  CONCLUSIONS
  Delafloxacin was similarly effective as tigecycline for a variety of complicated skin and skin-structure infections and was well tolerated. (Clinicaltrials.gov NCT 0719810).
authors.affiliation: eStudySite, 6367 Alvarado Court, Suite 300, San Diego, CA 92120, USA. Electronic address: woriordan@estudysite.com.
authors.forename: William
authors.initials: W
authors.lastname: O'Riordan
authors.affiliation: Artemis Research Group, 770 Washington Street, Suite 300, San Diego, CA 92103, USA.
authors.forename: Purvi
authors.initials: P
authors.lastname: Mehra
authors.affiliation: eStudySite, 6367 Alvarado Court, Suite 300, San Diego, CA 92120, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Manos
authors.affiliation: Southeast Regional Research Group, 5210 Armour Road, Suite 300, Columbus, GA 31904, USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Kingsley
authors.affiliation: Melinta Therapeutics, Inc., 300 George Street, Suite 301, New Haven, CT 06511, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Lawrence
authors.affiliation: Melinta Therapeutics, Inc., 300 George Street, Suite 301, New Haven, CT 06511, USA.
authors.forename: Sue
authors.initials: S
authors.lastname: Cammarata
mesh_terms: D000038:Abscess / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002481:Cellulitis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000031:analogs & derivatives / Q000627:therapeutic use; D000078304:Tigecycline; D014946:Wound Infection / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; C477891:delafloxacin; D000078304:Tigecycline; D008911:Minocycline
keywords: ABSSSIs; Delafloxacin; MRSA; MSSA; Polymicrobial skin infections