Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582186
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Individualization of First Maintenance Doses of Voriconazole Using a Multiparametric Algorithm in Hematology Patients a Prospective Single-arm Interventional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VORIPRECI
Brief Summary:
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
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
Detailed Description:
The currently recommended therapeutic drug monitoring of voriconazole has improved the efficacy of this treatment and reduced its adverse effects especially for treatment and prophylaxis of invasive aspergillosis However dose adjustments made as part of this therapeutic drug monitoring only occur at the earliest 3 to 5 days after the initiation of treatment whereas it is essential to achieve effective concentrations from the start of treatment Simple a priori dose adjustment approaches based on CYP2C19 genotype have been shown to improve voriconazole exposure and treatment response However other factors such as the patient39s inflammatory status or age also influence voriconazole exposure suggesting that strategies for individualizing initial voriconazole doses could be improved by integrating all covariates influencing voriconazole pharmacokinetics In this line a previous multicenter and international study has developped and validated an algorithm for calculating the first maintenance doses integrating not only the CYP2C19 genotype but also the inflammatory status the patient39s age and the presence or not of hematological malignancy Here the investigators propose to evaluate the interest of this multiparametric algorithm for improving initial exposure within the first 4 days to voriconazole in patients suffering from haematological malignancies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None