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Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem From a Phase 2, Randomized Clinical

Carl-Christian A Jackson1, Jason Newland2, Nataliia Dementieva3

  • 1From the Division of Pediatric Surgery, Tufts Children's Hospital, Boston, Massachusetts.

The Pediatric Infectious Disease Journal
|March 31, 2023
PubMed

Insights

Ceftolozane/tazobactam plus metronidazole demonstrated good tolerability and appeared effective for treating complicated intra-abdominal infections in pediatric patients. The safety profile was comparable to that observed in adults.

Area of Science:

  • Pediatric Infectious Diseases
  • Antimicrobial Therapy
  • Clinical Pharmacology

Background:

  • Ceftolozane/tazobactam is an approved cephalosporin-β-lactamase inhibitor combination for complicated urinary tract and intra-abdominal infections.
  • This study assessed the safety and efficacy of ceftolozane/tazobactam in pediatric patients with complicated intra-abdominal infections (cIAI).

Purpose of the Study:

  • To evaluate the safety and tolerability of intravenous ceftolozane/tazobactam plus metronidazole in pediatric participants with cIAI.
  • To assess clinical cure rates at end of treatment (EOT) and test of cure (TOC) as secondary endpoints.

Main Methods:

  • A phase 2, randomized study (NCT03217136) comparing ceftolozane/tazobactam+metronidazole to meropenem in pediatric participants (<18 years) with cIAI.
  • Primary objective: safety and tolerability assessment. Secondary objectives: clinical cure rates at EOT and TOC.

Main Results:

  • The modified intent-to-treat population comprised 91 pediatric participants; complicated appendicitis was the most frequent diagnosis.
  • Adverse events (AEs) were reported in 80.0% of those on ceftolozane/tazobactam+metronidazole versus 61.9% on meropenem; drug-related AEs were 18.6% and 14.3%, respectively.
  • Clinical cure rates at EOT were 80.0% for ceftolozane/tazobactam+metronidazole and 95.2% for meropenem; at TOC, rates were 80.0% and 100.0%, respectively.

Conclusions:

  • Ceftolozane/tazobactam plus metronidazole was well-tolerated in pediatric patients with cIAI, exhibiting a safety profile similar to adults.
  • The combination demonstrated apparent efficacy in this descriptive analysis of pediatric cIAI cases.
Abstract

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