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This phase II study will be conducted to:
This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.
The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posaconazole oral suspension | Drug |
Inclusion Criteria:
have a recurrence of fever (oral temperature, >38c or >100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16436724 | Result | Ullmann AJ, Cornely OA, Burchardt A, Hachem R, Kontoyiannis DP, Topelt K, Courtney R, Wexler D, Krishna G, Martinho M, Corcoran G, Raad I. Pharmacokinetics, safety, and efficacy of posaconazole in patients with persistent febrile neutropenia or refractory invasive fungal infection. Antimicrob Agents Chemother. 2006 Feb;50(2):658-66. doi: 10.1128/AAC.50.2.658-666.2006. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001228 | Aspergillosis |
| D002177 | Candidiasis |
| D009091 | Mucormycosis |
| D003453 | Cryptococcosis |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020096 | Zygomycosis |
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