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Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections

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ClinicalTrials.gov Identifier: NCT00015665
Recruitment Status : Completed
First Posted : April 30, 2001
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

This protocol provides for emergency treatment with the experimental anti-fungal drug voriconazole for patients with life-threatening invasive fungal infections. The increase in the number of patients whose immune function is suppressed because of chemotherapy, tissue or organ transplantation, or HIV infection has led to an increase in fungal infections. New drugs are needed to combat these infections in patients who do not respond to or cannot tolerate standard treatments.

Patients on other primary NIH protocols who have an invasive life-threatening fungal infection that does not respond to currently available treatments or who cannot tolerate these treatments may be eligible for this study.

Participants will have a blood test and a physical examination before receiving voriconazole. They will receive voriconazole twice a day either as an infusion into a vein or as tablets taken by mouth. Adult patients will be asked to provide a blood sample any time after the first dose of voriconazole to be used for developing a test to measure voriconazole concentration in the blood. Patients will be evaluated about 10 days after starting treatment and then at least once every 4 weeks with a symptom check and blood test.


Condition or disease Intervention/treatment Phase
Mycoses Drug: Voriconazole Phase 3

Detailed Description:

The increase in the number of immunosuppressed patients as a result of more aggressive chemotherapy, transplantation, HIV infection has lead to an increase in the incidence of invasive fungal infections. Moreover, despite the availability of newer, less toxic preparations of Amphotericin B and azole antifungals such as fluconazole and itraconazole, invasive mycoses remain a therapeutic challenge.

Voriconazole is a new triazole that has shown in phase II studies to be very active against Aspergillus sp. Its side effect profile has been very benign, comparable with those of other FDA approved triazoles. In vitro studies also show that voriconazole has a very broad spectrum ranging from opportunistic to endemic fungi. In addition, the availability of intravenous and oral formulations add to its potential advantages because the therapy of these infections usually require long courses on antifungals.

In this study, voriconazole is used as a salvage therapy for those patients who are unable to tolerate or who have failed other antifungal therapies. Because of the abundance of immunocompromised patients at our center, we believe that having such a protocol ready for enrollment would mitigate delays in such crucial moments. We seek to enroll and treat 40 patients over a 3 year period.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: Treatment
Official Title: Open-Label, Non-Comparative Protocol for the Emergency Use of Voriconazole in Patients With Life Threatening, Invasive Mycoses Who Are Failing on Currently Available Antifungal Agents
Study Start Date : April 2001
Estimated Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

All subjects must have a proven fungal infection that is resistant to standard therapy, or to which the patient is significantly intolerant. (Intolerance must include signs of intolerance such as fever, rigors, laboratory abnormalities, as well as subjective symptoms).

Children are eligible.

EXCLUSION CRITERIA:

AST, ALT greater than 10x the upper limit of normal

Previous hypersensitivity to azole antifungals

Concomitant Rifampin, carbamazepine, or barbiturates or greater than 3 days of such drugs in the 14 days prior to treatment with voriconazole

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015665


Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

ClinicalTrials.gov Identifier: NCT00015665     History of Changes
Other Study ID Numbers: 010150
01-I-0150
First Posted: April 30, 2001    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: March 2003

Keywords provided by National Institutes of Health Clinical Center (CC):
Fungal
Immunodeficiency
Infection
Refractory
Severe
Fungal Infections

Additional relevant MeSH terms:
Emergencies
Mycoses
Invasive Fungal Infections
Disease Attributes
Pathologic Processes
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors