Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003031
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
An Open Randomised Comparative Multicentre Study of the Efficacy Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis
PURPOSE Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis
PURPOSE Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis
Detailed Description:
OBJECTIVES I Compare the efficacy safety and toleration of voriconazole versus amphotericin B CAB in the treatment of acute invasive aspergillosis in immunocompromised patients II Compare the efficacy safety and toleration of voriconazole versus CAB followed by other antifungal therapy in the treatment of acute invasive aspergillosis in immunocompromised patients III Compare survival in patients treated with voriconazole versus CAB with or without other antifungal therapy IV Investigate resource utilization in patients treated with voriconazole versus CAB with or without other antifungal therapy
OUTLINE This is an open label randomized multicenter study Patients are stratified according to center site of infection underlying disease and baseline neutrophil count Patients are randomized to one of two treatment arms Arm I Patients receive voriconazole IV every 12 hours for 7-28 days and continue with oral voriconazole twice a day for a maximum total duration of 12 weeks of therapy Arm II Patients receive intravenous amphotericin B daily for at least 2 weeks treatment continues for a maximum of 12 weeks Patients discontinued from study drug treatment because of toxicity intolerance or clinical failure may receive alternative nonstudy antifungal therapy All patients are monitored for a total of 16 weeks
PROJECTED ACCRUAL A sufficient number of patients will be accrued so that 212 patients 106 per study arm will be eligible for the study
OUTLINE This is an open label randomized multicenter study Patients are stratified according to center site of infection underlying disease and baseline neutrophil count Patients are randomized to one of two treatment arms Arm I Patients receive voriconazole IV every 12 hours for 7-28 days and continue with oral voriconazole twice a day for a maximum total duration of 12 weeks of therapy Arm II Patients receive intravenous amphotericin B daily for at least 2 weeks treatment continues for a maximum of 12 weeks Patients discontinued from study drug treatment because of toxicity intolerance or clinical failure may receive alternative nonstudy antifungal therapy All patients are monitored for a total of 16 weeks
PROJECTED ACCRUAL A sufficient number of patients will be accrued so that 212 patients 106 per study arm will be eligible for the study
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 |
|---|---|---|---|
| PFIZER-150-307-000 | None | None | None |
| EORTC-19961 | None | None | None |