Protocol Number: 06-I-0077

Title:

Voriconazole Plasma Concentration and Toxicity

Number:

06-I-0077

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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 whose medical caretakers do not want the patient to enter.

Patients unable to give informed consent, due to the severity of their medical condition (Comatose patients, ICU patients under sedation).

Special Instructions:

Currently Not Provided

Keywords:

CYP2C9

CYP2C19

Pharmacology

Genotype

Metabolism

Recruitment Keyword(s):

Pharmacology

Condition(s):

Pharmacology

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

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.

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 withneutropenia and persistent fever.N Engl J Med. 2002 Jan 24;346(4):225-34.

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