NCT00537888Unknown4 期
Diagnosis of Pulmonary Candidiasis
Capital Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- invasive candidiasis
研究概览
简要总结
The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •85ys>age>14ys
- •APACHE II<25
- •Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
- •smear or culture positive for candida spp. from sputum
排除标准
- •Pregnancy
- •Hypersensitivity to fluconazole
- •Isolated candida was non-sensitive to fluconazole
- •Severe liver or renal diseases who can not tolerate fluconazole treatment
- •With at least one of the following high risk factors:organ transplantation, neutropenia>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
- •With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood
- •Probable or possible pulmonary aspergillosis
- •Definite oral or esophageal candidiasis
结局指标
主要结局
invasive candidiasis
时间窗: in hospital
次要结局
未报告次要终点
研究者
研究点 (1)
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