drugset / Trial / NCT02285075
Temocillin Pharmacokinetic in Hemodialysis
Phase 4
Completed
16 enrolled
AZ Sint-Jan AV
Ana Miranda Bastos, Louvain drug research institute, belgium · collabFrancoise Van Bambeke, Louvain drug research institute, belgium · collabPaul Tulkens, Louvain drug research institute, belgium · collab
NaSingle-groupOpen-labelTreatment
Summary
The current study aimed to explore the pharmacokinetics of temocillin in patients treated with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time above a MIC of 16 mg/L of more than 40 and 60 % of the dosing interval could be obtained with a dosing schedule of 1 gram/24 hours, 2 gram/48 hours and 3 gram/72 hours, all of these doses given after haemodialysis sessions only.
Timeline
- Start
- 2011-06
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- Results Miranda Bastos AC, Vandecasteele SJ, Tulkens PM, Spinewine A, Van Bambeke F. Development and validation of a high performance liquid chromatography assay for the determination of temocillin in serum of haemodialysis patients. J Pharm Biomed Anal. 2014 Mar;90:192-7. doi: 10.1016/j.jpba.2013.12.002. Epub 2013 Dec 12.
- Miranda Bastos AC, Vandecasteele SJ, Spinewine A, Tulkens PM, Van Bambeke F. Temocillin dosing in haemodialysis patients based on population pharmacokinetics of total and unbound concentrations and Monte Carlo simulations. J Antimicrob Chemother. 2018 Jun 1;73(6):1630-1638. doi: 10.1093/jac/dky078.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temocillin | Small molecule | 1 g | — |
| Subject | Temocillin | Small molecule | 2 g | — |
| Subject | Temocillin | Small molecule | 3 g | — |