drugset / Trial / NCT01664065
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function
Timeline
- Start
- 2013-02
- Primary completion
- 2013-11
- Completion
- 2013-11
Publications
- Background Sunzel M, Learoyd M, Li J, Li Y, Ngo N, Edeki T. An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis. Int J Antimicrob Agents. 2015 Dec;46(6):682-8. doi: 10.1016/j.ijantimicag.2015.09.009. Epub 2015 Oct 22.
- Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftaroline fosamil | Other / unclassified | 200 mg | Intravenous |
| Subject | Ceftaroline fosamil | Other / unclassified | 600 mg | Intravenous |