NCT02503449Unknown不适用
Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
Zhixin Liang0 个研究点目标入组 260 人开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 主要终点
- differences in clinical manifestations of pulmonary cryptococcosis
研究概览
简要总结
The purpose of the study:1.Improve the understanding of the risk factors of pulmonary cryptococcosis;2.Improve the awareness of pulmonary cryptococcosis clinical and imaging manifestations;3.Grasp pulmonary cryptococcosis patients of clinical and imaging manifestations in different conditions;4.Learn about antibacterial activity of antifungal drugs for cryptococcosis in China.
详细描述
- Patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals.
- Relevant case report forms are created in this study.
- Basic information such as age,weight and height is recorded in selected cases.Clinical manifestations,risk factors,laboratory examination,imaging examination,etiological examination and histopathological examination are also recorded in selected cases by case report forms.In addition,antifungal treatment is recorded including name,dose,time of starting treatment and terminate treatment.Causes of terminate treatment and curative effect evaluation should be analysed.
- Statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients possess clinical or imaging manifestations of pulmonary infections,with any of the results(by one of following conditions) by microbiological examination or histopathologic examination
- •Cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive
- •Cryptococcus（fungus culture) is discovered by lower respiratory tract specimens
- •Cryptococcus（pleural effusions culture) is discovered by pleural effusions collected under sterile condition
- •Cryptococcus（pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients
- •Cryptococcus（blood culture) is discovered by microscopy of specimens of blood smear
- •Cryptococcus is discovered by culturing of the pathological tissue specimens in aseptic condition
- •Cryptococcal capsular budding yeast with inflammatory reaction is discovered by histopathological examination,cell pathology examination or microscopic examination in aseptic condition
排除标准
- •Patients suffer from acquired immune deficiency syndrome
- •Patients or their legal guardians request to withdraw the clinical research
结局指标
主要结局
differences in clinical manifestations of pulmonary cryptococcosis
时间窗: 30 days
Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)
次要结局
- treatment of pulmonary cryptococcosis(30 days)
研究者
Zhixin Liang
Chinese Medical Association of respiratory diseases
Chinese PLA General Hospital
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