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Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonates and Children With Complicated Urinary

Emmanuel Roilides1, Negar Ashouri2, John S Bradley3

  • 1From the Third Department of Pediatrics, Infectious Diseases Unit, School of Medicine, Aristotle University and Hippokration General Hospital, Thessaloniki, Greece.

The Pediatric Infectious Disease Journal
|January 23, 2023
PubMed

Insights

Ceftolozane/tazobactam demonstrated a favorable safety profile and high efficacy in treating pediatric complicated urinary tract infections (cUTI). This antibiotic combination proved comparable to meropenem, offering a new option for children with resistant Gram-negative pathogens.

Area of Science:

  • Pediatric infectious diseases
  • Antimicrobial resistance
  • Pharmacology

Background:

  • Ceftolozane/tazobactam is approved for adult complicated urinary tract infections (cUTI).
  • This combination targets multidrug-resistant Gram-negative pathogens.
  • Pediatric safety and efficacy for cUTI were assessed.

Purpose of the Study:

  • To evaluate the safety and efficacy of ceftolozane/tazobactam in pediatric patients with cUTI.
  • To compare ceftolozane/tazobactam with meropenem in this population.
  • To assess clinical cure and microbiologic response rates.

Main Methods:

  • Phase 2 study (NCT03230838) in participants from birth to <18 years.
  • Comparison of ceftolozane/tazobactam versus meropenem for cUTI treatment.
  • Primary endpoint: safety and tolerability; secondary endpoints: clinical cure and microbiologic response.

Main Results:

  • 95 participants in the microbiologic modified intent-to-treat population.
  • Similar adverse event rates between ceftolozane/tazobactam and meropenem.
  • High clinical cure (88.7%-94.4%) and microbiologic eradication (84.5%-93.0%) rates for both treatments.

Conclusions:

  • Ceftolozane/tazobactam exhibits a favorable safety profile in pediatric cUTI.
  • High rates of clinical cure and microbiologic eradication were observed.
  • Ceftolozane/tazobactam is a safe and effective treatment option for pediatric cUTI, particularly against resistant Gram-negative bacteria.
Abstract

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