Voriconazole Blood Levels and Toxicity

NCT00359541 | Completed

• 2 other identifiers: 06007706-I-0077
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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 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

Keywords

CYP2C9; CYP2C19; Pharmacology; Genotype; Metabolism

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, at least 12 years old with no restriction of gender, race or disabilities, followed by the National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI) and National Heart Lung and Blood Institute (NHLBI) who begin treatment with voriconazole either oral or intravenous.
• Patients who have a previous voriconazole course at least 7 days before current course.

You may not qualify if:

• Time elapsed greater than 15 days from initiation of voriconazole treatment for inpatients and greater than 30 days from initiation of voriconazole treatment for outpatients.
• Patients who the medical staffs caring for the patient not want entered into the study.
• Patients unable to give informed consent, due to the severity of their medical condition (Comatose patients, ICU patients under sedation).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Jantunen E, Ruutu P, Niskanen L, Volin L, Parkkali T, Koukila-Kahkola P, Ruutu T. Incidence and risk factors for invasive fungal infections in allogeneic BMT recipients. Bone Marrow Transplant. 1997 Apr;19(8):801-8. doi: 10.1038/sj.bmt.1700737.

  PMID: 9134172 BACKGROUND

• Herbrecht R, Denning DW, Patterson TF, Bennett JE, Greene RE, Oestmann JW, Kern WV, Marr KA, Ribaud P, Lortholary O, Sylvester R, Rubin RH, Wingard JR, Stark P, Durand C, Caillot D, Thiel E, Chandrasekar PH, Hodges MR, Schlamm HT, Troke PF, de Pauw B; Invasive Fungal Infections Group of the European Organisation for Research and Treatment of Cancer and the Global Aspergillus Study Group. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med. 2002 Aug 8;347(6):408-15. doi: 10.1056/NEJMoa020191.

  PMID: 12167683 BACKGROUND

• Walsh TJ, Pappas P, Winston DJ, Lazarus HM, Petersen F, Raffalli J, Yanovich S, Stiff P, Greenberg R, Donowitz G, Schuster M, Reboli A, Wingard J, Arndt C, Reinhardt J, Hadley S, Finberg R, Laverdiere M, Perfect J, Garber G, Fioritoni G, Anaissie E, Lee J; National Institute of Allergy and Infectious Diseases Mycoses Study Group. Voriconazole compared with liposomal amphotericin B for empirical antifungal therapy in patients with neutropenia and persistent fever. N Engl J Med. 2002 Jan 24;346(4):225-34. doi: 10.1056/NEJM200201243460403.

  PMID: 11807146 BACKGROUND

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: January 19, 2006
• Study Completion: June 25, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-06-25

Locations

US (1)