Overview

Dosing Obese With Noxafil® Under a Trial (DONUT)

Status:
Completed
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified. There is clear evidence indicating that heavier patients are receiving a sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented prevalence of species with intermediate susceptible to posaconazole, adequate dosing is needed at start of treatment. Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.
Phase:
Phase 4
Details
Lead Sponsor:
Radboud University
Collaborators:
Merck Sharp & Dohme Corp.
St. Antonius Hospital
Treatments:
Posaconazole