Individualization of First Maintenance Doses of Voriconazole Using a Multiparametric Algorithm in Hematology Patients: a Prospective Single-arm Interventional Study (VORIPRECI)

NCT06582186 Phase 4 NOT_YET_RECRUITING

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.

Details

Lead sponsor	University Hospital, Grenoble
Phase	Phase 4
Status	NOT_YET_RECRUITING
Enrolment	30
Start date	2024-10
Completion	2027-10

Conditions

• Aspergillosis Invasive
• Fungal Infection
• Hematologic Malignancy

Interventions

• Individualization of first voriconazole maintenance doses

Primary outcomes

• Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range — Day 5 +/-2

Countries

France