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Voriconazole Blood Level and Liver Metabolizing Enzyme in Taiwanese Patients

NCT00745992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-02-10

No results posted yet for this study

Summary

Voriconazole is an effective antifungal agent and may decrease morbidity and mortality for patients with invasive fungal infections. It is metabolized via liver enzymes. However, these enzymes exhibit different activities in individual patient (genetic polymorphism). Higher proportions of Asians metabolize voriconazole slower than Caucasians and African Americans do. Slower metabolizers may experience dose-associated adverse events more frequently, such as visual disturbances, liver function test abnormalities, and neurological complications. On the other hand, extensive metabolizer or other physiologic conditions may lead to lower blood levels of voriconazole, which may result in treatment failure.

We plan to enroll patient who take voriconazole and examine their liver enzyme activities and blood samples for peak and trough drug levels. We will collect potential factors affecting voriconazole levels, and correlate the levels with the dosing regimen, activity of liver enzyme, occurrence of adverse events, and treatment outcomes. The goal of this study is to determine if monitoring of voriconazole blood levels is necessary in Taiwan.

Conditions

  • Invasive Fungal Infections

Interventions

OTHER

Blood drawn (lab data)

1. Check drug blood level 3-5 days after start of drug, treatment failure, occurence of adverse events, or clinically indicated 2. Check genetic polymorphism of liver enzyme 3-5 days after start of drug

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Shu-Wen Lin, PharmD, MS · Graduate Institute of Clinical Pharmacy, National Taiwan University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745992 on ClinicalTrials.gov