- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503449
Clinical Trial of Pulmonary Cryptococcosis in China (MCTOPCIC)
July 17, 2015 updated by: Zhixin Liang
Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Actual)
260
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Improve the understanding of the risk factors of pulmonary cryptococcosis.
- Improve the awareness of pulmonary cryptococcosis clinical and imaging manifestations.
- Grasp pulmonary cryptococcosis patients of clinical and imaging manifestations in different conditions.
- Learn about antibacterial activity of antifungal drugs for cryptococcosis in China.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
differences in clinical manifestations of pulmonary cryptococcosis
Time Frame: 30 days
|
Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
treatment of pulmonary cryptococcosis
Time Frame: 30 days
|
Efficacy as measured by recording dose and time of therapy for antifungal agents
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
December 28, 2014
First Submitted That Met QC Criteria
July 17, 2015
First Posted (Estimate)
July 21, 2015
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 17, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYN-316
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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