Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm

NCT06582186 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 38RC23.02302024-A01425-42
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspergillosis Invasive; Fungal Infection; Hematologic Malignancy

Keywords

model-informed precision dosing; single-arm prospective interventional study; Simon design

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range

  Day 5 +/-2

Secondary Outcomes (7)

• Frequency of initial plasma voriconazole trough concentrations above the therapeutic range

  Day 5 +/-2

• Frequency of initial plasma voriconazole trough concentrations below the therapeutic range

  Day 5 +/-2

• Voriconazole area under the curve (AUC0-12h) after the first maintenance dose individualized

  Day 2

• Time to get the therapeutic range

  through study completion, an average of 3 months

• Treatment outcome in patients curatively treated

  At month 3 +/- 15 days

Study Arms (1)

individualized maintenance doses

EXPERIMENTAL

Individualization of first maintenance doses through a multiparametric algorithm integrating CYP2C19 genotype, C reactive protein level and age

Drug: Individualization of first voriconazole maintenance doses

Interventions

Individualization of first voriconazole maintenance doses DRUG

Individualization of first voriconazole maintenance doses

individualized maintenance doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• comedication with strong inhibitors/inducers (valproic acid, phenytoin, carbamazepine, rifampicin)
• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Gautier-Veyret

Grenoble, 38043, France

Location

Related Publications (2)

• Gautier-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 BACKGROUND

• Bolcato 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 BACKGROUND

MeSH Terms

Conditions

Mycoses; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gautier-Veyret Elodie

  Grenoble Alps University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gautier-Veyret Elodie, PharmD, PhD

CONTACT

+33476765492; Egautier@chu-grenoble.fr

Thiebaut-bertrand Anne, MD

CONTACT

Athiebaut@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: September 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)