Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

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Brief Title

Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

NTM infection rates

Secondary Outcome

 clinical characteristics of patients with bronchiectasis comorbid NTM infections

Condition

Bronchiectasis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

216

Start Date

August 14, 2018

Completion Date

August 2021

Primary Completion Date

December 2020

Eligibility Criteria

        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
      

Gender

Female

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ben Cao, MD, 86 13621089726, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03594032

Organization ID

2018-62-K46


Responsible Party

Sponsor-Investigator

Study Sponsor

Bin Cao


Study Sponsor

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


Verification Date

December 2019