Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095
Public ClinicalTrials.gov record NCT00177749. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open Label, Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 evidence of clinical failure. No other tests will be performed specifically for the experimental treatment use protocol.
Study identification
- NCT ID
- NCT00177749
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2004
- Primary completion
- Not listed
- Completion
- Oct 31, 2006
- Last update posted
- Dec 16, 2008
2004 – 2006
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Fungal Infection trials
Other public records listing Fungal Infection. Sorted by last update posted; newest first. Not a recommendation.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00177749, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2008 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00177749 live on ClinicalTrials.gov.