EUCTR2009-014652-30-IT进行中（未招募）不适用
Efficacy, safety and pharmacokinetics of SPK-843 in the treatment of pulmonary mycosis.Phase III Open clinical study - ND
PRO APARTS SR0 个研究点开始时间: 2010年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 fungal etiology demonstrated by an examination of micologic culture (crop) and histopathological examination (patients with definite diagnosis), or patients with fungal infection which is difficult to determine the causative agent but with a diagnosis of deep mycosis based on serological test for fungal infection and / or clinical radiological investigation, and / or clinical endoscopic investigation, clinical symptoms (patients with clinical diagnosis). Patients treated with other antifungal drugs with a poor response to treatment after at least 5 days of administration of the antifungal drug, which had an adverse drug reaction that affects the use, considering the risk / benefit profile for the patient. Age between 18 and 75 years. Subjects are able to understand what is written in the form of informed consent and eager to participate in the trial. Male and female. Patients admitted to the hospital identified for the trial in question. Informed consent
- •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
- •Patients with clinical improvement of symptoms or a clinical course not clear, being treated with other antifungal drugs; patients with intravenous catheter and hospitalized with a diagnosis of fungemia, without clinical symptoms in 12 hours after removal of the catheter; patients with severe deep mycosis with a low probability of clinical efficacy (probability of occurrence with very high death), or severe concomitant diseases or complications that can lead to difficulties in assessing the safety in the treatment in question; Patients with a history of allergy to drugs such as AMPH-B or severe allergic reactions to drugs (shock after administration of several drugs by antifungals); patients with severe hepatic insufficiency, renal, cardiac or pulmonary disease or with the basic function test of body meeting the following criteria: - AST (GOT) or ALT (GPT) greater than 5 times the upper limit of normal or 200 IU / L; - Serum creatinine greater than 2.0 mg / dl; - Proteinuria (qualitative test) 3 + or higher, or total urinary excretion of protein (quantitative test) of 3.5 g / day or higher; - Hyperkalemia or hypokalemia, or baseline level of sodium of 6.0 mEq / L or greater or less than 2.5 mEq / L; - Hyperlipidaemia with a baseline total cholesterol greater than 1.5 times the upper limit of normal or 300 mg / dl, triglycerides greater than 2 times the upper limit of normal or 300 mg / dl; Patients who require an infusion of leukocytes; patients with arterial thrombosis or coagulation with severe dysfunction; patients with diabetes mellitus associated with ketosis; Women who are pregnant or wish to become pregnant, women in puerperium,breastfeeding women; Patients who have participated in a clinical study (with any kind of drugs including anticancer drugs) or who were enrolled for clinical observational studies with pharmaceutical agents in the previous month before the start of treatment with SPK-843; Patients who were not judged by the investigator to be eligible enrolled in the study in question.
研究者
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