Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095) (COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses
Intervention: Posaconazole oral suspension (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Schering-Plough
Summary
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.
Clinical Details
Official title: Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Detailed description:
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.
This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH
56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH
56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of
invasive fungal infections. Approximately 320 subjects have been enrolled at 160 clinical
study centers in the US and worldwide.
Eligibility
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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:
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole
antifungals.
- 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 effects: terfenadine, cisapride, ebastine at entry or within 24
hours prior to therapy, or astemizole at entry or within 10 days prior to
entry. concentration/efficacy of azole antifungals: rifampin, carbamazepine.
- Females pregnant or nursing.
Locations and Contacts
Additional Information
Starting date: April 2001
Ending date: October 2006
Last updated: May 14, 2007
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