Clinical trial · Interventional
Pharmacologic Optimization of Voriconazole
Pharmacologic Optimization of Voriconazole - a Prospective Clustered Group-randomized Cross-over Trial of Therapeutic Drug Monitoring
NCT00893555CI-TRIAL-00025465VORI911completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Invasive Fungal Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| voriconazole | Drug | — | UNRESOLVED |
| voriconazole (dosing according to the SPC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- Voriconazole dosing based on SPC
- interventionNames
- Drug: voriconazole (dosing according to the SPC)
- type
- EXPERIMENTAL
- label
- TDM
- description
- Voriconazole serum concentration based dosing
- interventionNames
- Drug: voriconazole
Primary outcomes (1)
- measure
- The primary clinical endpoint will be a global response consisting of a combined endpoint of toxicity and response to therapy (clinical, microbiologic and radiologic responses) 28 days after starting treatment with voriconazole.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * are at least 18 years of age * have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant * proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria * treatment with voriconazole Exclusion Criteria: * allergic to voriconazole or its excipients * age below 18 years
References
Publications (2)
- DERIVEDKlomp 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. PMID 39010708
- DERIVEDVeringa 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. PMID 36642232