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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02074462
Other study ID # VCZ-13O30
Secondary ID
Status Completed
Phase N/A
First received February 12, 2014
Last updated August 13, 2014
Start date January 2014
Est. completion date August 2014

Study information

Verified date August 2014
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (2)

Lead Sponsor Collaborator
University Medical Center Groningen Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

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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