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
The objective of this study is to evaluate the efficacy, safety and toleration of
voriconazole in the treatment of systemic or invasive fungal infections due to fungal
pathogens for which there is no licensed therapy or that are unresponsive or intolerant to
treatment with approved systemic antifungal agents. This trial is an extension of the Phase
III multicenter, open label study investigating the utilization of voriconazole for the
treatment of systemic or invasive fungal infections. Enrollment is targeted for 100
patients to be recruited from multiple centers. The patient population will consist of
patients with proven deeply invasive fungal infection for which there is no licensed therapy
or if the patient is failing or intolerant to treatment with approved systemic antifungal
agents and currently on the voriconazole (99-C-0094) protocol. Voriconazole will be
administered intravenously at 3-4 mg/kg q 12 hours or orally at 200-300 mg BID. Efficacy
will be evaluated by clinical, radiological and microbiological response.
Interventional
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
000024
NCT00001940
December 1999
July 2001
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |