title: Daptomycin for Complicated Skin Infections: A Randomized Trial.
abstract: BACKGROUND
  Complicated skin and skin structure infections (cSSSI) are common in children. Due to safety and resistance issues with recommended agents, new treatment options would be advantageous.
  
  
  METHODS
  Multicenter, evaluator-blinded clinical trial. Patients 1 to 17 years old with cSSSI caused by Gram-positive pathogens were randomized 2:1 to intravenous daptomycin or standard-of-care (SOC) treatment for ≤14 days. Daptomycin was administered once daily with dosing by patient age: 12 to 17 years, 5 mg/kg; 7 to 11 years, 7 mg/kg; 2 to 6 years, 9 mg/kg; 12 to 23 months, 10 mg/kg. The primary objective was to evaluate daptomycin safety. The secondary objective was to assess the efficacy of daptomycin compared with SOC. The intent-to-treat (ITT) population consisted of all randomized patients with any dose of study drug.
  
  
  RESULTS
  The ITT population comprised 257 daptomycin and 132 SOC patients (primarily clindamycin or vancomycin); 35% had confirmed methicillin-resistantStaphylococcus aureus. The most common adverse events were diarrhea (7% daptomycin, 5% SOC) and increased creatine phosphokinase (6% daptomycin, 5% SOC). The proportions of safety population patients with treatment-related adverse events were similar between the daptomycin (14%) and SOC (17%) groups. Clinical success rates (blinded evaluator-assessed complete/partial resolution of cSSSI signs and symptoms 7-14 days after end-of-treatment) in the ITT population were also similar for the daptomycin (91%) and SOC groups.
  
  
  CONCLUSIONS
  Once-daily daptomycin was well tolerated, with safety and efficacy comparable to SOC in children/adolescents with cSSSI caused by Gram-positive pathogens, including community-acquired methicillin-resistantS aureus.
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of California San Diego, San Diego, California; jbradley@rchsd.org.|Rady Children's Hospital, San Diego, California.
authors.forename: John
authors.initials: J
authors.lastname: Bradley
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Chad
authors.initials: C
authors.lastname: Glasser
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Hernando
authors.initials: H
authors.lastname: Patino
authors.affiliation: University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, Tennessee.
authors.forename: Sandra R
authors.initials: SR
authors.lastname: Arnold
authors.affiliation: Children's Hospital of Orange County, Orange, California.
authors.forename: Antonio
authors.initials: A
authors.lastname: Arrieta
authors.affiliation: Akron Children's Hospital, Akron, Ohio.
authors.forename: Blaise
authors.initials: B
authors.lastname: Congeni
authors.affiliation: MRSA Research Center, Department of Pediatrics, University of Chicago, Chicago, Illinois; and.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Daum
authors.affiliation: Children's Hospital at Montefiore, Bronx, New York.
authors.forename: Tsoline
authors.initials: T
authors.lastname: Kojaoghlanian
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Minjung
authors.initials: M
authors.lastname: Yoon
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Diane
authors.initials: D
authors.lastname: Anastasiou
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Dominik J
authors.initials: DJ
authors.lastname: Wolf
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Paula
authors.initials: P
authors.lastname: Bokesch
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002981:Clindamycin / Q000627:therapeutic use; D003402:Creatine Kinase / Q000097:blood; D017576:Daptomycin / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055624:Methicillin-Resistant Staphylococcus aureus; D016037:Single-Blind Method; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D014640:Vancomycin / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D002981:Clindamycin; D014640:Vancomycin; D003402:Creatine Kinase; D017576:Daptomycin