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Sponsors and Collaborators: |
University of Pittsburgh Schering-Plough |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177749 |
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 resistant to voriconazole and caspofungin. Yet, the only available therapeutic option, amphotericin, is associated with significant renal toxicity, even in lipid formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration (FDA) approved, but which has excellent in vitro activity against some intrinsically resistant fungi such as the zygomycetes.
The intent of this trial is to provide access to posaconazole to patients with serious fungal infections which are refractory to standard antifungal therapies or invasive fungal infections for which there are currently no effective therapies. Secondly, the drug will also be made available to patients with invasive fungal infections who:
This is a multicenter, open-label, non-comparative experimental treatment use protocol. The experimental treatment use protocol will provide the investigational medication posaconazole where no other drug is commercially available. Posaconazole is given as an orally or enterally administered suspension. The duration of therapy is at the discretion of the investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc interval prolongation) performed at baseline and serum/urine pregnancy testing performed at baseline and every three months after initiation of therapy. Plasma concentrations will be obtained if there is evidence of clinical failure. No other tests will be performed specifically for the experimental treatment use protocol.
Condition | Intervention | Phase |
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Fungal Infection |
Drug: Posaconazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | Open Label, Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095 |
Estimated Enrollment: | 10 |
Study Start Date: | August 2004 |
Study Completion Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Catherine Hardalo, MD | Schering-Plough |
Study ID Numbers: | IRB#0307071 |
Study First Received: | September 13, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00177749 History of Changes |
Health Authority: | United States: Food and Drug Administration |
invasive fungal infections |
Anti-Bacterial Agents Mycoses Clotrimazole Miconazole |
Antifungal Agents Tioconazole Posaconazole |
Trypanocidal Agents Anti-Infective Agents Mycoses Communicable Diseases Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Posaconazole Infection Pharmacologic Actions |