Voriconazole to Treat Fungal Infections
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|ClinicalTrials.gov Identifier: NCT00001940|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients.
Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop.
Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.
|Condition or disease||Intervention/treatment||Phase|
|Mycoses||Drug: Voriconazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Official Title:||An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||July 2001|
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): NCT00001940
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|