Clinical trial NCT02503449: Clinical Trial of Pulmonary Cryptococcosis in China
Official title: Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cryptococcosis
Keywords: Pulmonary Cryptococcosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Beijing Chao Yang Hospital
name: Ministry of Health, China
name: Peking University Third Hospital
name: Tianjin Medical University General Hospital
name: First Hospital of China Medical University
name: Shengjing Hospital
name: Second Hospital of Jilin University
name: Shandong Provincial Hospital
name: Huadong Hospital
name: Nanjing PLA General Hospital
name: Fuzhou General Hospital
name: Guangzhou Institute of Respiratory Disease
name: Wuhan TongJi Hospital
name: Xi'an Jiaotong University
name: Guizhou Provincial People's Hospital
name: Shenyang Military General Hospital
name: The Second Hospital of Hebei Medical University
name: Xiangya Hospital of Central South University
name: Fujian Provincial Hospital
name: Fuzhou Pulmonary Hospital of Fujian
name: Southwest Hospital, China
name: First Affiliated Hospital of Zhejiang University
name: Wenzhou Medical University
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Nanchang University
name: Longyan City First Hospital
First posted: 2015-07-21
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 1. Patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals.
2. Relevant case report forms are created in this study.
3. 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.
4. Statistical analysis.

Eligibility criteria: Inclusion Criteria:

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

1. Cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive
2. Cryptococcus（fungus culture) is discovered by lower respiratory tract specimens
3. Cryptococcus（pleural effusions culture) is discovered by pleural effusions collected under sterile condition
4. Cryptococcus（pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients
5. Cryptococcus（blood culture) is discovered by microscopy of specimens of blood smear
6. Cryptococcus is discovered by culturing of the pathological tissue specimens in aseptic condition
7. Cryptococcal capsular budding yeast with inflammatory reaction is discovered by histopathological examination,cell pathology examination or microscopic examination in aseptic condition

Exclusion Criteria:

1. Patients suffer from acquired immune deficiency syndrome
2. Patients or their legal guardians request to withdraw the clinical research

Primary outcomes:
measure: differences in clinical manifestations of pulmonary cryptococcosis
timeFrame: 30 days
Secondary outcomes:
measure: treatment of pulmonary cryptococcosis
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Zhixin Liang, Doctor
role: STUDY_DIRECTOR
affiliation: Beijing Chao Yang Hospital
name: Zhen Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, China
name: Yanming Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Lina Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University General Hospital
name: Jie Cao
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Yunzhuo Chu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Zhijie Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Jilin University
name: Yufen Jin
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Xiaobin Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Huadong Hospital
name: Yanping Zhu
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing PLA General Hospital
name: Xin Su
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuzhou General Hospital
name: Guoxiang Lai
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Institute of Respiratory Disease
name: Feng Ye
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan TongJi Hospital
name: Shengdao Xiong
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi'an Jiaotong University
name: Lan Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Guizhou Provincial People's Hospital
name: Hong Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang Military General Hospital
name: wencheng Xue
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Yadong Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital of Central South University
name: Chengping Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Provincial Hospital
name: Baosong Xie
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuzhou Pulmonary Hospital of Fujian
name: Xiaohong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Hospital, China
name: Xiangdong Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: Wenjiang Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Wenzhou Medical University
name: Yuping Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Hongni Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Wei Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: Longyan City First Hospital
name: Sucheng Zhong
role: PRINCIPAL_INVESTIGATOR
References: