Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001940
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Voriconazole to Treat Fungal Infections
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2000-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Voriconazole is a new drug developed to treat fungal infections As of March 1999 the drug had been studied in more than 1900 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 drugs 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
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
Detailed Description:
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 mgkg q 12 hours or orally at 200-300 mg BID Efficacy will be evaluated by clinical radiological and microbiological response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0024 | None | None | None |