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A Multicenter, Randomized, Observer-blinded, Active-controlled Study Evaluating the Safety and Effectiveness of

Jeffrey L Blumer1, Tina Ghonghadze, Christopher Cannavino

  • 1From 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.

The Pediatric Infectious Disease Journal
|April 15, 2016
PubMed

Insights

Ceftaroline fosamil demonstrated good tolerability and comparable clinical effectiveness against complicated community-acquired bacterial pneumonia in pediatric patients when compared to ceftriaxone plus vancomycin.

Area of Science:

  • Pediatric infectious diseases
  • Pharmacology and therapeutics

Background:

  • Ceftaroline, a broad-spectrum cephalosporin, exhibits in vitro activity against pathogens relevant to pediatric infections.
  • Ceftaroline fosamil is a prodrug of ceftaroline.

Purpose of the Study:

  • To evaluate the safety and efficacy of ceftaroline fosamil versus standard therapy (ceftriaxone plus vancomycin) in children with complicated community-acquired bacterial pneumonia.

Main Methods:

  • A multicenter, randomized, observer-blinded, active-controlled trial involving pediatric patients (2 months to 17 years).
  • Patients received intravenous ceftaroline fosamil or ceftriaxone plus vancomycin for at least 3 days, with potential switch to oral therapy.
  • Safety was assessed via treatment-emergent adverse events; effectiveness was determined by clinical and microbiologic outcomes.

Main Results:

  • Ceftaroline fosamil group (N=30) experienced fewer treatment-emergent adverse events (40%) compared to the comparator group (N=10, 80%).
  • Adverse events in both groups were generally mild to moderate.
  • Clinical response rates were 52% for ceftaroline fosamil and 67% for the comparator group.

Conclusions:

  • Ceftaroline fosamil is well-tolerated in pediatric patients with complicated community-acquired bacterial pneumonia.
  • The drug shows similar clinical response rates to the combination of ceftriaxone and vancomycin.
Abstract

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