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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00686621 |
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.
Condition | Intervention | Phase |
Mycoses |
Drug: Posaconazole |
Phase III |
MedlinePlus related topics: | Fungal Infections Molds |
ChemIDplus related topics: | Posaconazole |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections |
Enrollment: | 1 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Single arm: Experimental |
Drug: Posaconazole
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.
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Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Inclusion Criteria:
Safety Related Inclusion Criteria
Male or a female patient who meets any one of the following criteria:
Invasive Fungal Infection Inclusion Criteria
Each patient must have:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05113 |
First Received: | May 27, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00686621 |
Health Authority: | United States: Food and Drug Administration |
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