Effect of Inflammation on Voriconazole Concentration

Inflammation Clinical Trial

Official title:

Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074462
• Other study ID #: VCZ-13O30
• 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

• Fungal Infection
• Inflammation
• Mycoses

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