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Current Clinical Trials on the Use of Ceftaroline in the Pediatric Population

Adam Corey1, Tsz-Yin So2

  • 1UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27514, USA.

Clinical Drug Investigation
|April 7, 2017
PubMed

Insights

Ceftaroline fosamil is a new antibiotic approved for pediatric skin infections and pneumonia. It effectively treats resistant bacteria like MRSA and offers similar efficacy to adults.

Area of Science:

  • Pediatric infectious diseases
  • Antimicrobial resistance
  • Pharmacology

Background:

  • Rising antibiotic resistance in children necessitates novel therapeutic options.
  • Ceftaroline fosamil, a fifth-generation cephalosporin, offers broad-spectrum activity.
  • Approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in children over two months.

Purpose of the Study:

  • To review the clinical safety and efficacy of ceftaroline fosamil in pediatric patients.
  • To discuss the pharmacokinetic profile and dosing in children.
  • To explore ongoing research for expanded pediatric indications.

Main Methods:

  • Review of three pivotal pediatric clinical trials supporting FDA approval.
  • Analysis of pharmacokinetic data comparing pediatric and adult populations.
  • Examination of ongoing trials for new indications.

Main Results:

  • Ceftaroline fosamil demonstrates efficacy against key pediatric pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
  • Pediatric dosing maintains a similar pharmacokinetic profile and efficacy (time above minimum inhibitory concentration) to adults.
  • Clinical trials confirmed the safety and efficacy for approved indications.

Conclusions:

  • Ceftaroline fosamil is a valuable new antibiotic for treating specific bacterial infections in children.
  • Further research is evaluating its potential use in more severe pediatric conditions like sepsis, meningitis, and osteomyelitis.
  • The drug represents an important advancement in combating pediatric antibiotic resistance.

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