This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe and effective.
Invasive fungal infections are a major cause of morbidity and mortality in patients with haematological malignancy and haematopoietic stem cell transplantation. Voriconazole is routinely used as a first-line agent for the treatment of invasive aspergillosis, invasive fusariosis and scedosporiosis. Voriconazole has extreme pharmacokinetic variability. Adult patients with a trough concentration of \< 1 mg/L have a lower probability of clinical response whereas patients with trough concentrations \> 6 mg/L a higher probability of toxicity. Therapeutic drug monitoring for dose adjustment is advocated but there are no algorithms that enable voriconazole dosage to be reliably adjusted to achieve desired trough concentrations in a timely and optimally precise manner. Novel ways to deliver optimised antifungal therapy are urgently required and this trial will evaluate whether giving a patients a tailored dose of voriconazole is safe and effective. Plasma concentrations will be taken in real time and inputted in dose software that will calculate an optimum dose for the required trough concentration of 1-3 mg/L. The software has been developed using data from phase I and III trials of voriconazole.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
voriconazole will be administered in iv form
The Christie NHS Foundation Trust
Manchester, United Kingdom
Dose adjustment success
Dose adjustment success will be evaluated by plasma trough concentration on day 5, successful dose adjustment is defined as a trough concentration of 1-3 mg/L of voriconazole.
Time frame: Day 5 of treatment
Mortality of patients
To examine the mortality of patients receiving individualised voriconazole dosing
Time frame: 35 Day after starting treatment
Toxicity
To evaluate the adverse events that are attributable to voriconazole as assessed by CTCAE v4.
Time frame: Day 5 of treatment and 35 day follow-up
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