Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)(COMPLETED) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	May 1, 2002
Last Updated Date	May 31, 2006
Start Date ^†	January 1999
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00034658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)(COMPLETED)
Official Title ^†	Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections
Brief Summary	This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.
Detailed Description	The current clinical trial is designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections a)which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) 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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Mycoses
Intervention ^†	Drug: Posaconazole
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	337
Completion Date	September 2001
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria Proven or probable invasive fungal infections according to EORTC/MSG criteria. IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy. Able to take oral medication or take medication via enteral feeding tube. Exclusion Criteria Concurrent progressive neurological disease (except if due to invasive fungal infection) Use of medications that are known to interact with azoles and that may lead to life-threatening side to effects. Prior enrollment in this study. Subjects with a life expectancy of less than 72 hours.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00034658
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	May 2006
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.