Trials / Approved For Marketing
Approved For MarketingNCT00686621
Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)
Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- First posted
- 2008-05-30
- Last updated
- 2018-12-03
Source: ClinicalTrials.gov record NCT00686621. Inclusion in this directory is not an endorsement.