A Phase 4 interventional study of Individualization of first voriconazole maintenance doses in Aspergillosis Invasive, Fungal Infection and Hematologic Malignancy, sponsored by University Hospital, Grenoble. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by University Hospital, Grenoble · Phase 4, Interventional, and Treatment
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.
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 patient\'s 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 patient\'s 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.
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 30 is below the median of 68 across 164 interventional studies indexed under Mycoses.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Individualization of first voriconazole maintenance doses
Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range
Time frame: Day 5 +/-2
Frequency of initial plasma voriconazole trough concentrations above the therapeutic range
Time frame: Day 5 +/-2
Frequency of initial plasma voriconazole trough concentrations below the therapeutic range
Time frame: Day 5 +/-2
Voriconazole area under the curve (AUC0-12h) after the first maintenance dose individualized
Time frame: Day 2
Time to get the therapeutic range
Time frame: through study completion, an average of 3 months
Treatment outcome in patients curatively treated
Time frame: At month 3 +/- 15 days
Frequency of side effects
Time frame: through study completion, an average of 3 months
Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range
comparison with an historic cohort
Time frame: Day 5 +/-2
Plan to share: No
Start is estimated for Oct 2024; primary completion for Oct 2027, 36 months later.
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