drugset / Trial / NCT00893555
Pharmacologic Optimization of Voriconazole
Phase 3
Completed
189 enrolled
Jan-Willem C Alffenaar
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabAmsterdam UMC, location VUmc · collabErasmus Medical Center · collabHaga Hospital · collabKlinikum Oldenburg gGmbH · collabLeiden University Medical Center · collabMeander Medical Center · collabSt. Antonius Hospital · collabUMC Utrecht · collabUniversity Medical Center Nijmegen · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.
Timeline
- Start
- 2009-04
- Primary completion
- 2016-11
- Completion
- 2017-01
Outcome
Missed primary endpoint
paper Here, no significant difference was found between both groups (P = 0.678). PMID 36642232 ↗
paper In this trial, TDM-guided dosing of voriconazole did not show improved treatment outcome compared with standard dosing. PMID 36642232 ↗
Publications
- Klomp SD, Veringa A, Alffenaar JC, de Boer MGJ, Span LFR, Guchelaar HJ, Swen JJ. Inflammation altered correlation between CYP2C19 genotype and CYP2C19 activity in patients receiving voriconazole. Clin Transl Sci. 2024 Jul;17(7):e13887. doi: 10.1111/cts.13887.
- Veringa A, Bruggemann RJ, Span LFR, Biemond BJ, de Boer MGJ, van den Heuvel ER, Klein SK, Kraemer D, Minnema MC, Prakken NHJ, Rijnders BJA, Swen JJ, Verweij PE, Wondergem MJ, Ypma PF, Blijlevens N, Kosterink JGW, van der Werf TS, Alffenaar JC; Voriconazole ZonMw Study Group. Therapeutic drug monitoring-guided treatment versus standard dosing of voriconazole for invasive aspergillosis in haematological patients: a multicentre, prospective, cluster randomised, crossover clinical trial. Int J Antimicrob Agents. 2023 Feb;61(2):106711. doi: 10.1016/j.ijantimicag.2023.106711. Epub 2023 Jan 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Voriconazole | Small molecule | — | — |