ISRCTN11847553已完成4 期
Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult = 18 years
- •2. Patients with aplastic anaemia, MDS or AML undergoing:
- •2.1. IST; or
- •2.2. Intensive chemotherapy such as induction chemotherapy; or
- •2.3. RIC allogeneic HSCT
- •3. Able to swallow and retain orally administered medication
排除标准
- •1. Refusal or inability to consent
- •2. Autologous HSCT
- •3. Contraindicated medications
- •4. Current evidence of IFD diagnosis or treatment
- •5. Women who are pregnant or lactating
- •6. Enrolled in another study requiring alternative antifungal prophylaxis or treatment
- •7. Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study
研究者
相似试验
进行中（未招募）
1 期
Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole tablet ProphylaxisAplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantationMedDRA version: 19.0Level: LLTClassification code 10038271Term: Refractory anaemia with excess blasts in transformationSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10059041Term: Allogeneic peripheral haematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0Level: LLTClassification code 10067862Term: Allogeneic stem cell transplantationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0Level: PTClassification code 10038270Term: Refractory anaemia with an excess of blastsSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10010776Term: Constitutional aplastic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: LLTClassification code 10068063Term: Aplastic anaemia relapseSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: LLTClassification code 10036699Term: Primary idiopathic aplastic anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0Level: LLTClassification code 10000884Term: Acute myeloid leukaemia NOSSystem Organ Class: 10029104 -EUCTR2016-001223-31-GBKing's College Hospital NHS Foundation Trust150
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