EUCTR2010-020814-27-NL进行中（未招募）1 期
Empirical versus pre-emptive antifungal therapy of patients withhaematological malignanciesEmpirical versus pre-emptive (diagnosticdriven)antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase IIIstrategy study of the EORTC Infectious Diseases and Leukemia Groups.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 556
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18 years or older.
- •- Start within 3 days before randomization, remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months OR start within 3 days before randomization, myeloablative conditioning regimen to prepare for an allogeneic HSCT. Permissible conditioning regimens are outlined in Appendix E.
- •- Planned hospital admission for the duration of the neutropenic phase (ANC< 0.5 x 109 /L).
- •- Planned oral or intravenous (I.V.) fluconazole for Candida prophylaxis at the dose of 400 mg/day; no other antifungal systemic prophylaxis is allowed.
- •- Patients with childbearing potential must have a negative serum pregnancy test and use effective contraceptive methods during the treatment period and for at least 3 months after the last study treatment.
- •- Female subjects who are lactating should discontinue nursing prior to the first dose.
- •- Adequate contraception in men.
- •- Patients of childbearing/ reproductive potential should use adequate birth control measures as defined by the investigator. By adequate birth control measures should be understood highly effective methods as defined by the Note 3 of the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95):A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- •such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence or
- •vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on contraceptives should be addressed.
- •- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 556
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- Previous or current history of proven or probable IFD.
- •- Current clinical diagnosis of pneumonia.
- •- Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol.
- •- History of allergy or any adverse reaction to echinocandin drugs (caspofungin, micafungin, or anidulafungin).
- •- Inadequately treated infection at study entry.
- •- Documented HIV infection.
- •- Concomitant inclusion on other clinical trial using an investigational drug for infectious disease.
研究者
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