Study finds ceftolozane/tazobactam safe, effective for children with cUTIs
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A phase 2 randomized clinical trial found that ceftolozane/tazobactam was a safe and effective option for the treatment of children with complicated UTIs, researchers reported in The Pediatric Infectious Disease Journal.
Ceftolozane/tazobactam is already approved by the FDA, since last year, for the treatment of complicated UTI (cUTI) — including pyelonephritis — and complicated intra-abdominal infection (cIAI) in children.
“More options are needed for the treatment of antimicrobial-resistant infections, particularly for complicated UTIs that can be challenging to treat and are associated with significant morbidity,” co-author Matthew G. Johnson, MD, a senior principal scientist at Merck Research Laboratories, which manufactures ceftolozane/tazobactam as Zerbaxa, told Healio.
Ceftolozane/tazobactam has long been approved for use in adults, “so we want to ensure that children can also benefit from the use of ceftolozane/tazobactam,” Johnson said.
He clarified that because ceftolozane/tazobactam “has already been demonstrated to be effective for the treatment of cUTI in adults,” efficacy was “not the focal point” of the pediatric study.
“The primary purpose of the study was to evaluate the safety and tolerability of ceftolozane/tazobactam compared with meropenem, which is a common option for the treatment of cUTI in children and adults,” Johnson said. “A tandem study was also conducted in children with complicated intra-abdominal infection , and the results of both of these studies were combined to evaluate the safety of ceftolozane/tazobactam use in children.”
Johnson and colleagues compared ceftolozane/tazobactam with meropenem for the treatment of cUTIs in 95 children ranging from newborn to age 18 years, seeking to measure safety and tolerability.
A study group of 71 patients received ceftolozane/tazobactam and a control group of 24 received meropenem, with most common diagnoses including pyelonephritis and E. coli. Response rates for microbiologic eradication by end of treatment were 93% for ceftolozane/tazobactam and 95.8% for meropenem.
Ultimately, ceftolozane/tazobactam had a favorable safety profile, with results similar to meropenem. Johnson said the results were not surprising and aligned with the safety profile established for ceftolozane/tazobactam in adults.
“This study establishes that ceftolozane/tazobactam is a safe and effective new treatment option for antimicrobial-resistant gram-negative bacterial infections in children, including neonates and young infants, with cUTI,” Johnson said.
“Ceftolozane/tazobactam is currently being studied in children with nosocomial pneumonia, which involves a higher dose of ceftolozane/tazobactam for better lung penetration, just like in adults.”
References:
Jackson CCA, et al. Open Forum Infect Dis. 2021;doi:10.1093/ofic/ofab466.1347.
Roilides E, et al. Pediatr Infect Dis J. 2023;doi: 10.1097/INF.0000000000003832.