title: A Multicenter, Randomized, Observer-blinded, Active-controlled Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infection.
abstract: Ceftaroline has in vitro activity against bacterial isolates, including methicillin-resistant Staphylococcus aureus. This is the first study to investigate ceftaroline fosamil in pediatric patients with acute bacterial skin and skin structure infections (ABSSSIs).
  
  
  
  A multicenter, observer-blinded study (NCT01400867) in pediatric patients (2 months-17 years of age) with ABSSSIs. Patients were randomized 2:1 to receive intravenous (IV) ceftaroline fosamil or IV comparator (vancomycin or cefazolin, plus optional aztreonam) with optional switch to oral antibacterials from Day 4. Safety and clinical outcomes were assessed.
  
  
  
  Of 163 enrolled patients, 159 received treatment. Treatment groups were comparable for baseline characteristics. Rates of study drug-related treatment-emergent adverse events were similar for ceftaroline fosamil [22% (23/106)] and comparator [23% (12/53)]. One serious adverse event, considered to be related to IV study drug, occurred in the ceftaroline fosamil group (hypersensitivity). In both the treatment groups, 85% (ceftaroline fosamil, 91/107 and comparator, 44/52) of the modified intent-to-treat population achieved early clinical response (≥20% reduction in infection area from baseline). Clinical cure rates at test-of-cure were high [ceftaroline fosamil, 94% (101/107) and comparator, 87% (45/52)]. For patients evaluated 8 to 15 days after the last dose of any antibiotic (IV or oral), from whom methicillin-resistant Staphylococcus aureus was initially isolated, a favorable microbiologic response (reflecting the efficacy of oral/IV therapy and capturing a relapse or reinfection) was achieved with ceftaroline fosamil [89% (16/18)] and comparator [57% (4/7)].
  
  
  
  Ceftaroline fosamil, with optional oral switch, was as well-tolerated and effective in pediatric patients with ABSSSIs as comparator therapy.
authors.affiliation: From the *Pediatric Department, Medical College, University of Rzeszów, Rzeszów, Poland; †Department of Abdominal and Traumatology-Orthopedic Surgery, JSC M. Iashvili Children's Central Hospital, Tbilisi, Georgia; ‡Department of Pediatric Surgery, LTD, Children's New Clinic, Tbilisi, Georgia; §Division of Infectious Diseases, Department of Medicine, Centro de Educación Médica e Investigaciones Clinicas (CEMIC), Buenos Aires, Argentina; ¶Department of Clinical Development, Cerexa, Inc., Oakland, CA; and ‖Division of Infectious Diseases, Department of Pediatrics, University of California at San Diego, Rady Children's Hospital, San Diego, CA.
authors.forename: Bartosz
authors.initials: B
authors.lastname: Korczowski
authors.forename: Tinatin
authors.initials: T
authors.lastname: Antadze
authors.forename: Manana
authors.initials: M
authors.lastname: Giorgobiani
authors.forename: Martin E
authors.initials: ME
authors.lastname: Stryjewski
authors.forename: Alena
authors.initials: A
authors.lastname: Jandourek
authors.forename: Alexander
authors.initials: A
authors.lastname: Smith
authors.forename: Tanya
authors.initials: T
authors.lastname: O'Neal
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008826:Microbial Sensitivity Tests; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D013211:Staphylococcus aureus / Q000187:drug effects; D013297:Streptococcus pyogenes / Q000187:drug effects; D016896:Treatment Outcome; D000097583:Ceftaroline
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D000097583:Ceftaroline