Inflammation Clinical Trial
Official title:
Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age = 18 yrs - treatment with voriconazole - written informed consent Exclusion Criteria: - concomitantly using a strong inhibitor or inducer of CYP P450 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Pfizer |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation | Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS | Up to 1 month | No |
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