Historical Control Study of Refractory IFI or Patients Intolerant to Standard Antifungal Therapy in Patients With Invasive Fungal Infections (Study P02387)
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|ClinicalTrials.gov Identifier: NCT00230243|
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : March 10, 2017
|Condition or disease|
|Infection, Invasive Fungal|
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.
|Study Type :||Observational|
|Estimated Enrollment :||330 participants|
|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|
|Primary Completion Date :||September 2002|
|Study Completion Date :||September 2002|