Prevalence and Characteristics of Patients With Bronchiec... | NCT03594032

Studies
Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

NCT03594032

Sponsor

Bin Cao

Status

Unknown status

Last Update Posted

Jan 3, 2020Actual

Enrollment

216Estimated

Phase

Not provided

Conditions

Bronchiectasis
Non-tuberculous Mycobacterial

Interventions

Not provided

Countries

China

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2018Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Jul 11, 2018

First Submission Date that Met QC Criteria

Jul 11, 2018

First Posted Date

Jul 20, 2018Actual

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

Dec 31, 2019

Last Update Posted Date

Jan 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 this study is to Understand the prevalence of non-tuberculous mycobacterial(NTM) infections in the middle-aged and old women patients with bronchiectasis in Mainland China, and explore the characteristics of patients with bronchiectasis comorbid NTM.

Detailed Description

The development of bronchiectasis is closely related to chronic infection of pathogenic microorganisms .Bronchiectasis and nontuberculous mycobacterial (NTM) infections are inextricably linked Pathophysiologically. But the incidence rate and characteristics of NTM infections among patients with bronchiectasis remains unclear in mainland China.

In this study, we will collect data of participants about demographic ,co-morbidities ,spirometry, mMRC score ,exacerbation history, QOL-B questionnaire, aetiology, spirometry , HRCT(or CT) scan ,results of microbiology samples and treatments, collect three consecutive sputum(or induced sputum) samples to smear, bacteria culture, acid-fast stain, mycobacterium cultivation and identification, drug susceptibility testing of nontuberculous mycobacteria.To estimate the prevalance of non-tuberculous mycobacterial(NTM) infections in Middle-aged and old women patients with bronchiectasis in northern China. To analyze clinical manifestations and microbiological characteristics of patients with bronchiectasis comorbid NTM infections By 16SRNA and gene sequencing.

In addition, A cross-sectional investigation about lung function and clinical data will be done among patients who have confirmed bronchiectasis with NTM from February 2017 to December 2020.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NTM infection rates	NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China	24 months afer enrolled participants

Secondary Outcomes

Measure	Description	Time Frame
clinical characteristics of patients with bronchiectasis comorbid NTM infections	clinical manifestations of patients with bronchiectasis comorbid NTM infections	24 months afer enrolled participants
microbiological characteristics of patients with bronchiectasis comorbid NTM infections

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Middle-aged and old women who are > or = 50 years of age
Patients meet the criteria of bronchiectasis

Exclusion Criteria:

Cystic fibrosis
After organ transplantation
Activity tumor (malignant solid tumor and blood system tumor)
Pulmonary interstitial fibrosis with bronchus dilation
Allergic bronchopulmonary aspergillosis
Diffuse panbronchiolitis
Patients refused to sign the informed consent
Patients unable to return sputum specimens

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

216 patients with bronchiectasis who meet the below inclusion criteria will be re cruited in China-Japan Friendship Hospital in Beijing,China.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongjun Yin, MD	Contact	86 13621089726	861084206250	yhjh1101@163.com
Ben Cao, MD	Contact	86-010-84206264	8601084206264	caobin_ben@163.com

Overall Officials

Name	Affiliation	Role
Ben Cao, MD	China-Japan Friendship Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Friendship Hospital	Recruiting	Beijing		100029	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34872515	Derived	Yin H, Gu X, Wang Y, Fan G, Lu B, Liu M, Wang C, Cao B, Wang C. Clinical characteristics of patients with bronchiectasis with nontuberculous mycobacterial disease in Mainland China: a single center cross-sectional study. BMC Infect Dis. 2021 Dec 6;21(1):1216. doi: 10.1186/s12879-021-06917-8.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases