ClinConnect ClinConnect Logo
Search / Trial NCT06582186

Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Aug 29, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Model Informed Precision Dosing Single Arm Prospective Interventional Study Simon Design

ClinConnect Summary

This clinical trial is studying how to personalize the first maintenance doses of a medication called voriconazole for adults with blood cancers, specifically those at risk for serious fungal infections like aspergillosis. The goal is to use a special algorithm that considers factors such as a person's genetic makeup, inflammation level, and age to determine the best dose for each patient. By doing this, researchers hope to ensure that patients receive the right amount of medication from the start, which is important for effective treatment.

To be eligible for this trial, participants must be adults with a blood cancer, be receiving care at a specific hospital, and agree to a genetic test. They should also be starting treatment with voriconazole either to cure an infection or to prevent one. Participants will be asked to provide written consent to join the study. It's worth noting that people who are taking certain other medications or who have specific legal or health circumstances may not be able to participate. This trial is not yet recruiting participants, but it aims to improve treatment for patients facing serious fungal infections.

Gender

ALL

Eligibility criteria

  • 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)

About University Hospital, Grenoble

The University Hospital of Grenoble is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. As a prominent sponsor of clinical trials, the hospital leverages its expertise in various medical disciplines to facilitate cutting-edge studies that aim to improve treatment outcomes and enhance patient safety. With a strong commitment to collaboration, the University Hospital of Grenoble engages in partnerships with academic institutions, industry leaders, and regulatory bodies to drive scientific discovery and translate research findings into clinical practice. Its state-of-the-art facilities and multidisciplinary teams ensure rigorous adherence to ethical standards and regulatory guidelines, fostering an environment where groundbreaking research can thrive.

Locations

Grenoble, , France

Patients applied

0 patients applied

Trial Officials

Gautier-Veyret Elodie

Principal Investigator

Grenoble Alps University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported