Fungal Infection Clinical Trial
Official title:
A Prospective, Randomized Trial Comparing the Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing
This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary objective of this study will be to assess the effect of prospective voriconazole TDM on the composite of adverse events (AE) and clinical response.
This is a prospective study of patients who receive voriconazole as treatment for an IMI
(proven, probable, and possible by the EORTC/MSG definitions), other than zygomycosis.
Patients will be randomized to receive either standard dosing or dosing based on TDM,
stratified by whether initial voriconazole therapy is PO or IV. Assessment of outcomes will
be made 42 days after start of voriconazole. An additional follow up for safety reporting
will be performed 4weeks after completion of voriconazole
The patients will be randomized to:
- Prospective TDM: voriconazole dose will be adjusted based on per protocol obtained TDM
levels, and
- Standard dosing: standard doses of voriconazole will be used.
In the prospective TDM arm, voriconazole TDM will be performed in real time at each site and
results will be reported to treating physicians for dose adjustment. All efforts will be
taken to obtain results within 24 hours of blood sample collection. In the standard dosing
arm, blood samples will be collected, stored, and batched for voriconazole levels to be
tested retrospectively. Voriconazole plasma levels will be measured by validated high
performance liquid chromatography (HPLC) assays as detailed. Voriconazole trough levels will
be performed on Day Baseline/Screening, 5, 14, 28, and 42.
Voriconazole peak level will be measured on Day 5. Trough voriconazole levels will be
obtained in case of an event, defined as suspected drug-associated toxicity and/or clinical
failure.
Assessment of AEs for all patients will be monitored during the study and response to
treatment will be assessed. The composite of overall AE/clinical failure will be assessed on
day 42.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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