Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)(COMPLETED)
The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections|
- Clinical efficacy and safety of use [ Time Frame: Clinical outcome and adverse events measured every 3 months until the drug is marketed in the country. ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: Single arm||
Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day.
Other Name: SCH 056592
NCT00686621 was voluntarily registered even though it is a single patient use study, also known as compassionate exemption study; therefore results will not be disclosed for this study.