EUCTR2009-015159-26-DE进行中（未招募）不适用
KW-Inf-001: Prospective trial to evaluate pharmacokinetic, safety and efficacy of intermittent application of increased doses of caspofungin for antifungal prophylaxis in high risk patients. - CASPHYLAX
niversitaetsklinikum Wuerzburg0 个研究点目标入组 25 人开始时间: 2010年11月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •Patients with acute myeloid leukemia or myelodysplastic syndrome and blast
- •crisis or acute lymphatic leukemia
- •The patient is receiving induction chemotherapy, starting within 5 days
- •before and 4 days after enrollment.
- •The patient has an expected duration of neutropenia (neutrophils < 500/µl) for
- •at least 10 days
- •The patient has no proven or probable invasive Aspergillus infection within
- •12 months prior to enrollment
- •For women with childbearing potential, the patient has a negative serum or
- •urine pregnancy test within 48 hours of enrollment and the patient agrees to
- •use adequate birth control measures as defined by the investigator. Oral
- •contraceptives should not be used as the sole method of birth control.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient received systemic antifungal therapy with liposomal amphotericin
- •B, amphotericin B deoxycholate, caspofungin, anidulafungin, micafungin,
- •voriconazole, itraconazole or posaconazole (oral or I.V. for the azoles) but
- •not fluconazole within 3 days prior to enrollment
- •The patients had a proven or probable invasive Aspergillus infection within
- •12 months prior to enrollment.
- •The patient has a possible aspergillosis, due to the following criteria within
- •14 days of enrollment:
- •o positive galactomannan (OD> 0.5) in serum twice or more times or at
- •least one time in bronchioalveolar fluid
- •o pulmonary infiltrates in the computer tomography of the chest suspicious
- •for fungal infection (positive halo-, air-crescent sign, nodular). Patients
- •with pulmonary infiltrates on conventional chest x-ray, should undergo
- •further evaluation with a CT scan before enrollment if clinically
- •The patient is participating in another trial with an investigational drug during
- •the last 14 days before start of prophylaxis.
- •The patient has a history of allergy, hypersensitivity or any serious reaction to
- •caspofungin or any echinocandin.
- •Women, who are pregnant or breastfeeding.
- •The patient has a positive HIV test or known HIV infection
- •The patient has a known drug abuse.
- •The patient’s weight is more than 100 kg
- •The patient has one or more of the following abnormal laboratory values
- •- Serum total bilirubin > 5 times upper limit of normal
- •- INR > 1.6 (INR > 4.0, if the patient is receiving anticoagulation)
- •- Serum ASAT (SGOT) or ALAT (SGPT) > 5 times upper limit of normal
- •The patient is receiving hemodialyses for severe renal failure
- •The patient has a moderate or severe hepatic insufficiency (Child Pugh score
- •>6), acute hepatitis or cirrhosis due to any cause
- •The patient has a life expectancy below 5 days
- •The patient is receiving rifampin, cyclosporin A, efavirenz, nevirapine,
- •carbamazepine, phenytoin.
- •The patient has any concomitant illness which, in the opinion of the
- •investigator, might confuse the results of the study or pose additional risk in
- •administering caspofungin to the patient.
研究者
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