Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034671
Status:
COMPLETED
Last Update Posted:
2015-12-31
First Post:
2002-05-01
Brief Title:
PKPD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections Study P01893
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Phase II Study of Safety Tolerance Efficacy and Pharmacokinetics of Posaconazole SCH 56592 for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts
Status:
COMPLETED
Status Verified Date:
2015-12
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 phase II study will be conducted to
1 evaluate the pharmacokinetics safety tolerance and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
2 identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population
1 evaluate the pharmacokinetics safety tolerance and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
2 identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population
Detailed Description:
This is an open-label randomized parallel group study of pharmacokinetics safety tolerance and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy
The projected number of subjects planned for enrollment is 100 evaluable subjects The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world
The projected number of subjects planned for enrollment is 100 evaluable subjects The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world
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