Fungal Infection, Inflammation
Conditions
Keywords
Voriconazole, CRP, Inflammation, Pharmacokinetics
Brief summary
Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.
Interventions
None listed
Sponsors
Pfizer
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 yrs * treatment with voriconazole * written informed consent
Exclusion criteria
* concomitantly using a strong inhibitor or inducer of CYP P450
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation | Up to 1 month | Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS |
Countries
Netherlands
Outcome results
None listed