Voriconazole Blood Levels and Toxicity
Public ClinicalTrials.gov record NCT00359541. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Voriconazole Plasma Concentration and Toxicity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00359541
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2006
- Primary completion
- Not listed
- Completion
- Jun 24, 2010
- Last update posted
- Jul 1, 2017
2006 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00359541, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00359541 live on ClinicalTrials.gov.