NCT02503449

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

December 28, 2014

Last Update Submit

July 17, 2015

Conditions

Keywords

Pulmonary Cryptococcosis

Outcome Measures

Primary Outcomes (1)

  • differences in clinical manifestations of pulmonary cryptococcosis

    Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)

    30 days

Secondary Outcomes (1)

  • treatment of pulmonary cryptococcosis

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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)

MeSH Terms

Conditions

Cryptococcosis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Zhixin Liang, Doctor

    Chinese PLA General Hospital

    STUDY DIRECTOR
  • 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

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chinese Medical Association of respiratory diseases

Study Record Dates

First Submitted

December 28, 2014

First Posted

July 21, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

July 21, 2015

Record last verified: 2015-07