Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)
NCT00686621 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2018-12-03
Summary
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.
Conditions
- Mycoses
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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