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.