Clinical Trial of Pulmonary Cryptococcosis in China | NCT02503449

Studies
Clinical Trial of Pulmonary Cryptococcosis in China

NCT02503449

Sponsor

Zhixin Liang

Status

Unknown status

Last Update Posted

Jul 21, 2015Estimated

Enrollment

260Actual

Phase

Not provided

Conditions

Cryptococcosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 28, 2014

First Submission Date that Met QC Criteria

Jul 17, 2015

First Posted Date

Jul 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2015

Last Update Posted Date

Jul 21, 2015Estimated

Name	Class
Chinese PLA General Hospital	OTHER
Beijing Chao Yang Hospital	OTHER
Ministry of Health, China	OTHER_GOV
Peking University Third Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

260Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
treatment of pulmonary cryptococcosis	Efficacy as measured by recording dose and time of therapy for antifungal agents	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections