title: A Multicenter, Randomized, Observer-blinded, Active-controlled Study Evaluating the Safety and Effectiveness of Ceftaroline Compared With Ceftriaxone Plus Vancomycin in Pediatric Patients With Complicated Community-acquired Bacterial Pneumonia.
abstract: The broad-spectrum cephalosporin ceftaroline, a metabolite of the prodrug ceftaroline fosamil, has shown in vitro activity against clinical isolates from pediatric patients.
  
  
  
  This multicenter, randomized, observer-blinded, active-controlled study (NCT01669980) assessed the safety and effectiveness of ceftaroline fosamil compared with ceftriaxone plus vancomycin in patients between 2 months and 17 years of age with complicated community-acquired bacterial pneumonia. Patients were randomized 3:1 (stratified by age cohort) to receive either ceftaroline fosamil or ceftriaxone plus vancomycin (comparator) as intravenous therapy for ≥3 days. Patients who met specific study criteria on or after Study Day 4 were permitted to switch to an oral study drug. Safety assessments were treatment-emergent adverse events, and the effectiveness of treatment was assessed by clinical and microbiologic outcomes.
  
  
  
  The median duration of intravenous treatment was 9.0 (range, 3.0-19.0) days in the ceftaroline fosamil group (N=30) and 7.5 (5.0-13.0) days in the comparator group (N=10). At least one treatment-emergent adverse event was experienced by 12/30 patients (40%) in the ceftaroline fosamil group and 8/10 (80%) in the comparator group; most treatment-emergent adverse events in both groups were mild to moderate in intensity. Clinical response rates in the modified intent-to-treat population were 52% (15/29 patients) in the ceftaroline fosamil group and 67% in the comparator group (6/9); clinical stability at Study Day 4 was 21% (6/29) and 22% (2/9), respectively.
  
  
  
  Ceftaroline fosamil was well tolerated and showed similar clinical response rates to ceftriaxone plus vancomycin in pediatric patients with complicated community-acquired bacterial pneumonia.
authors.affiliation: From the *Toledo Children's Hospital, Toledo, Ohio; †Children's New Clinic, Tbilisi, Georgia; ‡University of California at San Diego and Rady Children's Hospital, San Diego, California; and §Cerexa, Inc., Oakland, California.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Blumer
authors.forename: Tina
authors.initials: T
authors.lastname: Ghonghadze
authors.forename: Christopher
authors.initials: C
authors.lastname: Cannavino
authors.forename: Tanya
authors.initials: T
authors.lastname: O'Neal
authors.forename: Alena
authors.initials: A
authors.lastname: Jandourek
authors.forename: Hillel David
authors.initials: HD
authors.lastname: Friedland
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000009:adverse effects; D002511:Cephalosporins / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D017714:Community-Acquired Infections / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D018410:Pneumonia, Bacterial / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D014640:Vancomycin / Q000008:administration & dosage* / Q000009:adverse effects; D000097583:Ceftaroline
chemical_list: D000900:Anti-Bacterial Agents; D002443:Ceftriaxone; D002511:Cephalosporins; D014640:Vancomycin; D000097583:Ceftaroline