Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230243
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2005-09-28
Brief Title:
Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections Study P02387
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections
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 retrospective study is designed to provide a consistent method of screening and collecting data on patients who will serve as controls for a comparison of the efficacy of the available antifungal therapies used as salvage treatments for patients with refractory IFI or for patients with refractory IFI or for patients with IFI who are intolerant to standard antifungal therapies
Detailed Description:
The current clinical trial is designed to provide historicals controls comparable to the P00041 study population that is a patients with invasive fungal infections which are refractory or resistant to standard antifungal therapies or b patients who have developed intolerance to standard antifungal therapy This clinical trial also serves to allow collection of historical data regarding the efficacy of available antifungal therapies against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled randomized clinical trial
This trial will be conducted primarily at the investigative sites that enrolled subjects into P00041 andor investigators who are members of the Mycosis Study Group
This trial will be conducted primarily at the investigative sites that enrolled subjects into P00041 andor investigators who are members of the Mycosis Study Group
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