Pediatric Phase 1 Trial Shows Ceftolozane/Tazobactam Is Safe,Tolerable

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Pharmacokinetic and safety data for new drugs in pediatric patients ensures healthcare providers have access to accurate dosing information, which can improve clinical outcomes in children.
Pharmacokinetic and safety data for new drugs in pediatric patients ensures healthcare providers have access to accurate dosing information, which can improve clinical outcomes in children.

Single doses of ceftolozane and tazobactam were well tolerated in children with gram-negative bacterial infections and no safety concerns were identified, according to a study published in The Pediatric Infectious Disease Journal.

A total of 37 pediatric patients age 7 days to <18 years participated in a phase 1, noncomparative, open-label, multicenter study. Of these, 34 were included in the pharmacokinetic population (ClinicalTrials.gov NCT02266706). All patients had a suspected or established gram-negative infection or were receiving perioperative prophylaxis. Participants were enrolled into 1 of 6 age-based groups to receive a single age-appropriate dose of ceftolozane/tazobactam. A timed blood sample was collected to determine plasma concentrations of ceftolozane and tazobactam.

Pharmacokinetic parameters for both drugs were comparable for patients age 3 months to <18 years, whereas those younger than 3 months of age had lower clearance. No deaths, serious study drug-related adverse events, or clinically significant laboratory abnormalities were observed.

The study was limited by the small sample size. This is common for pediatric pharmacokinetic studies because of enrollment difficulties stemming from scientific, regulatory, and ethical challenges. The data did however “provide further evidence that clearance of beta-lactams is higher in children and adolescents than in adults.” The results also supported continued development of future pediatric trials by informing models used to derive dose recommendations for phase 2 clinical trials.

 

Reference

 

Bradley JS, Ang JY, Arrieta AC, et al. Pharmacokinetics and safety of single intravenous doses of ceftolozane/tazobactam in children with proven or suspected gram-negative infection [published online August 27, 2018] Pediatr Infect Dis J. doi: 10.1097/INF.0000000000002170

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