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Voriconazole Blood Levels and Toxicity

NCT00359541 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will look at how voriconazole, a drug used to treat or protect against fungal infections, affects the body. Adverse effects associated with voriconazole include skin problems and temporary changes in vision, mental status and liver function. There is some evidence that these side effects may be more intense when there are high levels of the drug in the blood. The amount of voriconazole in the body is determined by how much of the drug the patient receives and by the patient's ability to inactivate and excrete it, which may be determined in part by genes. This study will examine: 1) side effects patients develop from voriconazole; 2) whether the side effects experienced are related to the concentration of drug in the body; and 3) the role of genes in determining how quickly the body inactivates and excretes the drug.

Patients 12 and older who are participating in studies in the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI) or the National Heart, Lung, and Blood Institute (NHLBI) and have been treated with voriconazole for 15 days or less may be eligible for this study.

Participation involves the following:

* Identification and recording of adverse effects patients experience due to voriconazole treatment
* Collection of basic information about the patient's medical history and treatment
* Blood draws once a week during the patient's hospitalization
* Collection of routine laboratory test results ordered by the patient's doctor
* Blood draw to identify genes responsible for voriconazole inactivation
* Weekly monitoring for the possibility of voriconazole adverse effects
* Blood draw to measure blood levels of voriconazole when the drug is stopped, if it is stopped because of an adverse effect
* Evaluations at outpatient visits, including a blood draw to measure voriconazole blood levels

Participation in the study ends 7 days after voriconazole treatment is stopped because it is no longer needed.

Conditions

  • Pharmacology

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-19
Completion
2010-06-25

Countries

  • United States

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 NCT00359541 on ClinicalTrials.gov