MCTOPCIC: Clinical Trial of Pulmonary Cryptococcosis in China

Sponsor

Zhixin Liang (Other)

Overall Status

Unknown status

CT.gov ID

NCT02503449

Collaborator

Chinese PLA General Hospital (Other), Beijing Chao Yang Hospital (Other), Ministry of Health, China (Other), Peking University Third Hospital (Other), Tianjin Medical University General Hospital (Other), First Hospital of China Medical University (Other), Shengjing Hospital (Other), Second Hospital of Jilin University (Other), Shandong Provincial Hospital (Other), Huadong Hospital (Other), Nanjing PLA General Hospital (Other), Fuzhou General Hospital (Other), Guangzhou Institute of Respiratory Disease (Other), Wuhan TongJi Hospital (Other), Health Science Center of Xi'an Jiaotong University (Other), Guizhou Provincial People's Hospital (Other), Shenyang Military General Hospital (Other), The Second Hospital of Hebei Medical University (Other), Xiangya Hospital of Central South University (Other), Fujian Provincial Hospital (Other), Fuzhou Pulmonary Hospital of Fujian (Other), Southwest Hospital, China (Other), First Affiliated Hospital of Zhejiang University (Other), Wenzhou Medical University (Other), Shanghai Zhongshan Hospital (Other), The First Affiliated Hospital of Nanchang University (Other), Longyan City First Hospital (Other)

260

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cryptococcosis

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

260 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multi-center Clinical Trial of Pulmonary Cryptococcosis in China

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Outcome Measures

Primary Outcome Measures

differences in clinical manifestations of pulmonary cryptococcosis [30 days]
Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)

Secondary Outcome Measures

treatment of pulmonary cryptococcosis [30 days]
Efficacy as measured by recording dose and time of therapy for antifungal agents

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Investigators

Study Director: Zhixin Liang, Doctor, Chinese PLA General Hospital
Principal Investigator: Zhen Wang, Beijing Chao Yang Hospital
Principal Investigator: Yanming Li, Ministry of Health, China
Principal Investigator: Lina Sun, Peking University Third Hospital
Principal Investigator: Jie Cao, Tianjin Medical University General Hospital
Principal Investigator: Yunzhuo Chu, First Hospital of China Medical University
Principal Investigator: Zhijie Zhang, Shengjing Hospital
Principal Investigator: Yufen Jin, Second Hospital of Jilin University
Principal Investigator: Xiaobin Ma, Shandong Provincial Hospital
Principal Investigator: Yanping Zhu, Huadong Hospital
Principal Investigator: Xin Su, Nanjing PLA General Hospital
Principal Investigator: Guoxiang Lai, Fuzhou General Hospital
Principal Investigator: Feng Ye, Guangzhou Institute of Respiratory Disease
Principal Investigator: Shengdao Xiong, Wuhan TongJi Hospital
Principal Investigator: Lan Yang, Health Science Center of Xi'an Jiaotong University
Principal Investigator: Hong Yu, Guizhou Provincial People's Hospital
Principal Investigator: wencheng Xue, Shenyang Military General Hospital
Principal Investigator: Yadong Yuan, The Second Hospital of Hebei Medical University
Principal Investigator: Chengping Hu, Xiangya Hospital of Central South University
Principal Investigator: Baosong Xie, Fujian Provincial Hospital
Principal Investigator: Xiaohong Chen, Fuzhou Pulmonary Hospital of Fujian
Principal Investigator: Xiangdong Zhou, Southwest Hospital, China
Principal Investigator: Wenjiang Ma, First Affiliated Hospital of Zhejiang University
Principal Investigator: Yuping Li, Wenzhou Medical University
Principal Investigator: Hongni Jiang, Shanghai Zhongshan Hospital
Principal Investigator: Wei Bai, The First Affiliated Hospital of Nanchang University
Principal Investigator: Sucheng Zhong, Longyan City First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhixin Liang, Chinese Medical Association of respiratory diseases, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT02503449

Other Study ID Numbers:

LYN-316

First Posted:

Jul 21, 2015

Last Update Posted: