A Single Center, Open-label Trial of Isavuconazole Prophylaxis Against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)
研究概览
简要总结
The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of greater than or equal to 18 years of age of either sex and of any race.
- •Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder.
排除标准
- •Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA.
- •History of allergy or intolerance to ISA.
- •Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal.
- •Familial short QT syndrome.
研究组 & 干预措施
Isavuconazole prophylaxis
Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.
干预措施: Isavuconazole (Drug)
结局指标
主要结局
Clinical Failure of Isavuconazole Prophylaxis by Week + 26 Post Hematopoietic Stem Cell Transplant (HCT)
时间窗: 26 weeks post HCT
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
Clinical Failure of Isavuconazole Prophylaxis by Week + 14 Post Hematopoietic Stem Cell Transplant (HCT)
时间窗: 14 weeks post HCT
Clinical failure is measured by: 1. Systemic antifungal therapy for \> 14 consecutive days for suspected fungal infection up to week 14. 2. Breakthrough proven or probable fungal infection during the prophylaxis phase.\* 3. Toxicity leading to permanent discontinuation of prophylaxis 4. Adverse event requiring discontinuation. * The prophylaxis phase was defined as the period from the first dose of isavuconazole through 7 days after discontinuation of isavuconazole.
次要结局
未报告次要终点