Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03594032
• Other study ID #: 2018-62-K46
• Status: Recruiting
• Start date: August 14, 2018
• Est. completion date: August 2021

Study information

• Verified date: December 2019
• Source: Capital Medical University
• Contact: Hongjun Yin, MD
• Phone: 86 13621089726
• Email: yhjh1101[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Non-tuberculous Mycobacterial

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bin Cao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NTM infection rates	NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China	24 months afer enrolled participants
Secondary	clinical characteristics of patients with bronchiectasis comorbid NTM infections	clinical manifestations of patients with bronchiectasis comorbid NTM infections	24 months afer enrolled participants
Secondary	microbiological characteristics of patients with bronchiectasis comorbid NTM infections	microbiological characteristics of patients with bronchiectasis comorbid NTM	24 months afer enrolled participants
Secondary	Drug resistance of NTM	drug susceptibility testing outcomes of nontuberculous mycobacteria from sputum samples	24 months afer enrolled participants