NCT00079222已完成不适用
Randomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
详细描述
OBJECTIVES:
- Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation.
OUTLINE: This is a randomized study. Patients are stratified according to donor type (related vs unrelated). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT), patients receive voriconazole IV twice daily on days 1-14 and then orally* twice daily on days 15-100.
- Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days 1-2, once daily on days 3-14, and then orally* twice daily on days 15-100.
NOTE: *Patients unable to tolerate oral medication may continue IV medication beyond day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 12 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Voriconazole With or Without Interferon Gamma in Treating Patients With Aspergillosis or Other Fungal InfectionsInfectionUnspecified Adult Solid Tumor, Protocol SpecificNCT00059878National Cancer Institute (NCI)
已完成
1 期
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell TransplantationChronic Myeloproliferative DisordersGestational Trophoblastic TumorInfectionMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsTesticular Germ Cell TumorBreast CancerOvarian CancerLymphomaLeukemiaNeuroblastomaNCT00064311National Institutes of Health Clinical Center (CC)
已完成
3 期
Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow TransplantationCancerNCT00003883Fred Hutchinson Cancer Center578
终止
2 期
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune SystemsInfectionUnspecified Adult Solid Tumor, Protocol SpecificNCT00238355OHSU Knight Cancer Institute13
已完成
3 期
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)Antifungal Prophylaxis of Invasive Fungal InfectionsNCT00289991Pfizer489