Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

December 31, 2019 updated by: Bin Cao

Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
        • Principal Investigator:
          • Hongjun Yin, MD

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Cystic fibrosis
  2. After organ transplantation
  3. Activity tumor (malignant solid tumor and blood system tumor)
  4. Pulmonary interstitial fibrosis with bronchus dilation
  5. Allergic bronchopulmonary aspergillosis
  6. Diffuse panbronchiolitis
  7. Patients refused to sign the informed consent
  8. Patients unable to return sputum specimens

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical characteristics of patients with bronchiectasis comorbid NTM infections
Time Frame: 24 months afer enrolled participants
clinical manifestations of patients with bronchiectasis comorbid NTM infections
24 months afer enrolled participants
microbiological characteristics of patients with bronchiectasis comorbid NTM infections
Time Frame: 24 months afer enrolled participants
microbiological characteristics of patients with bronchiectasis comorbid NTM
24 months afer enrolled participants
Drug resistance of NTM
Time Frame: 24 months afer enrolled participants
drug susceptibility testing outcomes of nontuberculous mycobacteria from sputum samples
24 months afer enrolled participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bin Cao

Investigators

  • Study Chair: Ben Cao, MD, China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 14, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-62-K46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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