Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001810
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
An Open Label Non-Comparative Multicenter Phase III Trial of the Efficacy Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open Label Non-Comparative Multicenter Phase III Trial of the Efficacy Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Status:
COMPLETED
Status Verified Date:
2000-04
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:
The objective of this study is to evaluate the efficacy safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents This trial is a Phase II multicenter open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections Enrollment is targeted for 150 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 Voriconazole will be administered initially by a loading dose of 6 mgkg q12 hours for the first two doses followed by 4 mgkg q12 hours Efficacy will be evaluated by clinical radiological and microbiological response
Detailed Description:
The objective of this study is to evaluate the efficacy safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents This trial is a Phase III multicenter open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections Enrollment is targeted for 150 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 Voriconazole will be administered initially by a loading dose of 6 mgkg q12 hours for the first two doses followed by 4 mgkg q12 hours 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 |
|---|---|---|---|
| 99-C-0094 | None | None | None |