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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

  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

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhixin Liang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wenzhou Medical University
The First Affiliated Hospital of Nanchang University
Xiangya Hospital of Central South University
Shanghai Zhongshan Hospital
Chinese PLA General Hospital
The Second Hospital of Hebei Medical University
Peking University Third Hospital
Southwest Hospital, China
Ministry of Health, China
Shengjing Hospital
First Affiliated Hospital of Zhejiang University
Shandong Provincial Hospital
Beijing Chao Yang Hospital
Guizhou Provincial People's Hospital
Fuzhou Pulmonary Hospital of Fujian
Guangzhou Institute of Respiratory Disease
Tianjin Medical University General Hospital
First Hospital of China Medical University
Health Science Center of Xi'an Jiaotong University
Second Hospital of Jilin University
Fuzhou General Hospital
Wuhan TongJi Hospital
Fujian Provincial Hospital
Nanjing PLA General Hospital
Huadong Hospital
Shenyang Military General Hospital
Longyan City First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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