Clinical trial · Interventional
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
Individualization of First Maintenance Doses of Voriconazole Using a Multiparametric Algorithm in Hematology Patients: a Prospective Single-arm Interventional Study
- 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 goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult patients with haematological malignancies. The main objective it aims is to determine the percentage of patients with initial voriconazole trough concentrations in the therapeutic range after individualization of first maintenance doses. Participants will benefited from individualization of first voriconazole maintenance doses through a previously developed and validated multiparametric algorithm (publication in progress) taking into account CYP2C19 genotype, C reactive protein level and age.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aspergillosis Invasive | — | UNRESOLVED | — |
| Fungal Infection | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualization of first voriconazole maintenance doses | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- individualized maintenance doses
- description
- Individualization of first maintenance doses through a multiparametric algorithm integrating CYP2C19 genotype, C reactive protein level and age
- interventionNames
- Drug: Individualization of first voriconazole maintenance doses
Primary outcomes (1)
- measure
- Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range
- timeFrame
- Day 5 +/-2
Secondary outcomes (7)
- measure
- Frequency of initial plasma voriconazole trough concentrations above the therapeutic range
- timeFrame
- Day 5 +/-2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patient suffering from haematological malignancy * followed in the clinical hematology department or in the hematology day hospital of the Grenoble Alps University Hospital * consenting to carrying out CYP2C19 genotyping * likely to start treatment with voriconazole (for curative or prophylactic purposes as part of care) * having signed a written consent to participate * affiliated to a social security system Exclusion Criteria: * comedication with strong inhibitors/inducers (valproic acid, phenytoin, carbamazepine, rifampicin) * Subject during exclusion period from another study, * Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons subject to care psychiatric pursuant to articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research , minors, person subject to a legal protection measure or unable to express their consent)
References
Publications (2)
- BACKGROUNDGautier-Veyret E, Thiebaut-Bertrand A, Roustit M, Bolcato L, Depeisses J, Schacherer M, Schummer G, Fonrose X, Stanke-Labesque F. Optimization of voriconazole therapy for treatment of invasive aspergillosis: Pharmacogenomics and inflammatory status need to be evaluated. Br J Clin Pharmacol. 2021 Jun;87(6):2534-2541. doi: 10.1111/bcp.14661. Epub 2020 Dec 13. PMID 33217017
- BACKGROUNDBolcato L, Khouri C, Veringa A, Alffenaar JWC, Yamada T, Naito T, Lamoureux F, Fonrose X, Stanke-Labesque F, Gautier-Veyret E. Combined Impact of Inflammation and Pharmacogenomic Variants on Voriconazole Trough Concentrations: A Meta-Analysis of Individual Data. J Clin Med. 2021 May 13;10(10):2089. doi: 10.3390/jcm10102089. PMID 34068031