drugset / Trial / NCT01893346
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
Non-randomizedSingle-groupOpen-labelBasic science
Summary
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to \<18 years.
Timeline
- Start
- 2013-07
- Primary completion
- 2014-10
- Completion
- 2014-10
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, Armstrong J, Arrieta A, Bishai R, Das S, Delair S, Edeki T, Holmes WC, Li J, Moffett KS, Mukundan D, Perez N, Romero JR, Speicher D, Sullivan JE, Zhou D. Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6252-9. doi: 10.1128/AAC.00862-16. Print 2016 Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftazidime | Small molecule | 40 mg/kg | Intravenous |
| Subject | Ceftazidime | Small molecule | 50 mg/kg | Intravenous |
| Subject | Ceftazidime | Small molecule | 2000 mg | Intravenous |
| Subject | avibactam | Small molecule | 10 mg/kg | Intravenous |
| Subject | avibactam | Small molecule | 12.5 mg/kg | Intravenous |
| Subject | avibactam | Small molecule | 500 mg | Intravenous |