Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)(COMPLETED)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mycoses |
Drug: Posaconazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections |
| Estimated Enrollment: | 337 |
| Study Start Date: | January 1999 |
| Estimated Study Completion Date: | September 2001 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00034658 History of Changes |
| Other Study ID Numbers: | P00041 |
| Study First Received: | May 1, 2002 |
| Last Updated: | May 31, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
Aspergillosis, Candidiasis, Cryptococcosis, |
Additional relevant MeSH terms:
|
Mycoses Posaconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 21, 2013