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NCT00177749 · ClinicalTrials.gov registry record · Phase 4
Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095
A Phase 4 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT00177749 is a Phase 4 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 10 participants.
The verdict
NCT00177749, a Phase 4 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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 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: * have experienced serious or severe toxicities while receiving standard antifungal therapies; * have pre-existing renal dysfunction which precludes use of standard antifungal therapies; or * are chronically immunosuppressed with a history of invasive fungal infections previously treated with posaconazole in other clinical trials, and who require oral antifungal suppressive therapy as maintenance treatment to prevent recurrence. 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
Interventions
- DRUG Posaconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-08 |
| Est. Completion | 2006-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00177749
The ClinicalTrials.gov registry entry for NCT00177749 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Posaconazole is the first listed.
NCT00177749 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00177749 about?
NCT00177749 is a clinical study titled "Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095". 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 as...
What is the current status of trial NCT00177749?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2004-08. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00177749?
The interventions under investigation include: Posaconazole (DRUG).
Who is sponsoring clinical trial NCT00177749?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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