Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)
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.
Infection, Invasive Fungal
|Study Design:||Time Perspective: Retrospective|
|Official Title:||A Retrospective Study to Establish an Historical Database on the Efficacy of Standard Antifungal Therapy in Patients With Invasive Fungal Infections|
|Study Start Date:||March 1997|
|Study Completion Date:||September 2002|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
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 and/or investigators who are members of the Mycosis Study Group.
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