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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00044486 |
Purpose
This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections.
Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome.
Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Neutropenia |
Drug: Posaconazole oral suspension |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Controlled Trial of Posaconazole (SCH 56592) Vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | May 2005 |
This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | P01899 |
| Study First Received: | August 29, 2002 |
| Last Updated: | May 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00044486 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prophylaxis neutropenia AML MDS |
fungal infections Acute Myelogenous Leukemia Anticipated prolonged profound neutropenia |
|
Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Precancerous Conditions Leukocyte Disorders Leukemia, Myeloid, Acute Leukemia Antiparasitic Agents Preleukemia Pathologic Processes Syndrome Antifungal Agents Therapeutic Uses |
Antibiotics, Antifungal Posaconazole Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Agranulocytosis Leukemia, Myeloid Pharmacologic Actions Neutropenia Neoplasms Bone Marrow Diseases Leukopenia |