Effect of Inflammation on Voriconazole Concentration
- Conditions
- InflammationFungal Infection
- Registration Number
- NCT02074462
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- age ≥ 18 yrs
- treatment with voriconazole
- written informed consent
- concomitantly using a strong inhibitor or inducer of CYP P450
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands