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OpenTrials
Completed

NCT Number: NCT02074462

Effect of Inflammation on Voriconazole Concentration

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.

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Key information

Conditions

Inflammation Bacterial Infections and Mycoses Fungal Infection Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 yrs
  • treatment with voriconazole
  • written informed consent

Exclusion criteria

  • concomitantly using a strong inhibitor or inducer of CYP P450

Treatment and study plan

Primary outcomes

  1. Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation

    Time frame: Up to 1 month

    Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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