Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044486
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2002-08-29
Brief Title:
Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients Study P01899
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Controlled Trial of Posaconazole SCH 56592 vs Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is in high risk patients to determine the safety and efficacy of posaconazole vs fluconazole in the prophylaxis against development of invasive fungal infections
Profound prolonged neutropenia Absolute neutrophil count500 cellscubic mm for at least 7 days due to induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome
Treatment Duration maximum of 12 weeks Follow-Up 2 months Endpoints incidence of proven or probable IFI according to EORTCMSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review
Profound prolonged neutropenia Absolute neutrophil count500 cellscubic mm for at least 7 days due to induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome
Treatment Duration maximum of 12 weeks Follow-Up 2 months Endpoints incidence of proven or probable IFI according to EORTCMSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review
Detailed Description:
This study is designed to determine the safety tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes
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