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Clinical Trial of Pulmonary Cryptococcosis in China (MCTOPCIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02503449
Recruitment Status : Unknown
Verified July 2015 by Zhixin Liang, Chinese PLA General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Collaborators:
Chinese PLA General Hospital
Beijing Chao Yang Hospital
Ministry of Health, China
Peking University Third Hospital
Tianjin Medical University General Hospital
First Hospital of China Medical University
Shengjing Hospital
Second Hospital of Jilin University
Shandong Provincial Hospital
Huadong Hospital
Nanjing PLA General Hospital
Fuzhou General Hospital
Guangzhou Institute of Respiratory Disease
Wuhan TongJi Hospital
Health Science Center of Xi'an Jiaotong University
Guizhou Provincial People's Hospital
Shenyang Military General Hospital
The Second Hospital of Hebei Medical University
Xiangya Hospital of Central South University
Fujian Provincial Hospital
Fuzhou Pulmonary Hospital of Fujian
Southwest Hospital, China
First Affiliated Hospital of Zhejiang University
Wenzhou Medical University
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Nanchang University
Longyan City First Hospital
Information provided by (Responsible Party):
Zhixin Liang, Chinese PLA General Hospital

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
Cryptococcosis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. treatment of pulmonary cryptococcosis [ Time Frame: 30 days ]
    Efficacy as measured by recording dose and time of therapy for antifungal agents


Biospecimen Retention:   Samples Without DNA
sputum,whole blood,pleural effusion,lung tissue,cerebrospinal fluid,fungus(smear examination,culture and identification,antigen detection,drug sensitive test)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503449


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

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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: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Keywords provided by Zhixin Liang, Chinese PLA General Hospital:
Pulmonary Cryptococcosis
Additional relevant MeSH terms:
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Cryptococcosis
Mycoses