Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)

Summary

This study will assess the safety, tolerability and efficacy of ceftazidime and avibactam (CAZ-AVI )versus cefepime in children from 3 months to less than 18 years old with complicated urinary tract infections.

Timeline

Start

2015-09-24

Primary completion

2017-09-15

Completion

2017-09-15

Publications

• Franzese RC, McFadyen L, Watson KJ, Riccobene T, Carrothers TJ, Vourvahis M, Chan PLS, Raber S, Bradley JS, Lovern M. Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime-Avibactam in Pediatric Patients Aged 3 Months and Older. Clin Pharmacol Ther. 2022 Mar;111(3):635-645. doi: 10.1002/cpt.2460. Epub 2021 Nov 22.
• Bradley JS, Roilides E, Broadhurst H, Cheng K, Huang LM, MasCasullo V, Newell P, Stone GG, Tawadrous M, Wajsbrot D, Yates K, Gardner A. Safety and Efficacy of Ceftazidime-Avibactam in the Treatment of Children >/=3 Months to <18 Years With Complicated Urinary Tract Infection: Results from a Phase 2 Randomized, Controlled Trial. Pediatr Infect Dis J. 2019 Sep;38(9):920-928. doi: 10.1097/INF.0000000000002395.

Drugs

Indications