Status:
TERMINATED
Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Schering-Plough
Conditions:
Fungal Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Therapeutic options for serious fungal infections are limited by intrinsic and acquired resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are intrinsically resist...
Detailed Description
This is an open-label, multi-center limited access experimental treatment use protocol of Posaconazole in the treatment of Invasive Fungal Infections. This experimental treatment use protocol is proje...
Eligibility Criteria
Inclusion
- A proven, probable, or possible invasive fungal infection which is refractory to standard antifungal therapies after a reasonable trial of standard antifungal therapy
- A proven, probable, or possible invasive fungal infection with a prior history of serious, severe, or life-threatening toxicities related to antifungal therapy
- A proven, probable, or possible invasive fungal infection with documented organ dysfunction (such as renal dysfunction defined as serum creatinine \> 2.5 mg/dL or estimated creatinine clearance \< 25 mL/minute), which precludes the continued administration of standard antifungal therapy
- A proven or probable invasive fungal infection for which there are currently no other clinically reasonable effective therapies
- A history of a proven or probable invasive fungal infection previously treated with posaconazole in a chronically immunosuppressed patient that requires oral antifungal suppressive therapy.
- A proven or probable invasive fungal infection in patients who have failed a reasonable trial of other licensed antifungal agents, either due to progression or lack of improvement of the infection
- A history of proven or probable invasive fungal infection in patients requiring ongoing antifungal therapy as chronic maintenance after initial control of disease with other antifungal agents, but who have become intolerant to licensed azoles. In these cases where long term parenteral antifungal therapy (e.g., amphotericin B or echinocandins) is not considered practical or clinically reasonable by the physician, posaconazole may be considered to be a potential treatment option.
- Patients with debilitating but no immediately life threatening fungal diseases, where significant morbidity may result in disability and where prior antifungal therapy has been unsuccessful (e.g., chronic candidiasis with dehydration and malnutrition, or cutaneous phaeohyphomycosis and mycetoma).
Exclusion
- Females who are pregnant or who continue to breast feed infants.
- History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals
- Subjects who require ongoing treatment with any prohibited medication and for whom an appropriate washout period has not elapsed. Those drugs known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry; those known to lower the serum concentration/efficacy of azole antifungal agents: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; and those receiving vinca alkaloids, or anthracyclines with evidence of cardiotoxicity.
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the experimental treatment use protocol, ie, any condition requiring the use of prohibited drugs or unstable medical conditions other than a hematological disorder such as unstable cardiac disorder (including acute myocardial infarction or unstable myocardial ischemia/angina within 30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or atrial fibrillation/flutter with symptomatic bradycardia \[sick sinus syndrome\], or unstable congestive heart failure) or impairment expected to be unstable or progressive during the course of this experimental treatment use protocol (eg, recurrent or uncontrolled seizure disorders, demyelinating syndromes, or progressive peripheral neuropathy).
- Subjects receiving vinca alkaloids or anthracyclines within 24 hours of enrollment or requiring therapy with vinca alkaloids or anthracyclines within the next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring ongoing therapy with vinca alkaloids or anthracyclines
- Subjects requiring ongoing systemic antifungal agents in addition to investigational medication (combination use is not permitted without prior authorization of the sponsor project physician).
- Subjects with an ECG with QTc interval greater than 450 msec for men, and greater than 470 msec for women at entry or within seven days prior to entry
- Any condition requiring the use of prohibited drugs
- Hepatic function tests: alanine amino transferase (ALT) or aspartate amino transferase (AST) \> 10 times upper limit of normal.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00177749
Start Date
August 1 2004
End Date
November 1 2006
Last Update
December 17 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213