Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

• Conditions: Bronchiectasis; Non-tuberculous Mycobacterial

• Registration Number: NCT03594032
• Lead Sponsor: Bin Cao

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 Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-20
• Study Start: 2018-08-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-31
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-12
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 216

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China