Aspergillosis Clinical Trial
Official title:
PIVOTAL: Pharmacological Individualisation of VOriconazole Therapy for AntifungaL Treatment
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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