Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359541
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-08-01
Brief Title:
Voriconazole Blood Levels and Toxicity
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Voriconazole Plasma Concentration and Toxicity
Status:
COMPLETED
Status Verified Date:
2010-06-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 patients medical history and treatment
Blood draws once a week during the patients hospitalization
Collection of routine laboratory test results ordered by the patients 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
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 patients medical history and treatment
Blood draws once a week during the patients hospitalization
Collection of routine laboratory test results ordered by the patients 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
Detailed Description:
Voriconazole VfendRegistered Trademark Pfizer has achieved common usage at the NIH National Institutes of Health Clinical Research Center for the treatment of fungal infections in immunosuppressed patients Toxicity includes relatively frequent but reversible changes in vision and more infrequent potentially serious hepatotoxicity decreased cognitive function and rash Incidence of these more serious adverse events has been difficult to ascertain because of the morbidity of underlying disease in patients receiving voriconazole but a minimum estimate is 10 percent It is known that voriconazole plasma concentrations vary between patients over a fifty-fold range but it is not known whether toxicity is related to plasma drug exposure The reason for the differing voriconazole plasma concentrations between normal individuals is partly due to genetic variations in hepatic cytochrome enzymes CYP2C9 and CYP2C19 Cytochrome P450 family 2 subfamily C polypeptide 9 and 19 respectively In patients with underlying illness drug interactions and decreased hepatic drug clearance may contribute to variability
The purpose of the study is to record prospectively the adverse effects of voriconazole in Clinical Center patients who have been prescribed the drug by their primary physician We will ask the primary physician to order a trough voriconazole plasma levels once a week The test will not be reported to the physician Because interpretation of the test is unknown the physicians will be blinded to the report Rather the primary objective of the study is to analyze the voriconazole plasma concentrations when the study is completed to determine if there is a concentration and duration of drug exposure that correlates with toxicity A secondary objective is to determine the 2C9 and 2C19 genotype of patients and search for possible correlations between genotype and plasma voriconazole concentrations Administration of other drugs given to the patient will be tracked to analyze whether any previously unknown drug interactions seem to have changed the voriconazole plasma concentration The study will also determine the incidence of adverse effects of voriconazole in our patient population
The purpose of the study is to record prospectively the adverse effects of voriconazole in Clinical Center patients who have been prescribed the drug by their primary physician We will ask the primary physician to order a trough voriconazole plasma levels once a week The test will not be reported to the physician Because interpretation of the test is unknown the physicians will be blinded to the report Rather the primary objective of the study is to analyze the voriconazole plasma concentrations when the study is completed to determine if there is a concentration and duration of drug exposure that correlates with toxicity A secondary objective is to determine the 2C9 and 2C19 genotype of patients and search for possible correlations between genotype and plasma voriconazole concentrations Administration of other drugs given to the patient will be tracked to analyze whether any previously unknown drug interactions seem to have changed the voriconazole plasma concentration The study will also determine the incidence of adverse effects of voriconazole in our patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-I-0077 | None | None | None |