Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

NCT ID: NCT03594032

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-14

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Bronchiectasis Non-tuberculous Mycobacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bin Cao

OTHER

Sponsor Role lead

Responsible Party

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Bin Cao

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ben Cao, MD

Role: STUDY_CHAIR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongjun Yin, MD

Role: CONTACT

86 13621089726 ext. 861084206250

Ben Cao, MD

Role: CONTACT

86-010-84206264 ext. 8601084206264

Facility Contacts

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Bin Cao, MD

Role: primary

86-010-84206264

Hongjun Yin, MD

Role: backup

86 13621089726

References

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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.

Reference Type DERIVED
PMID: 34872515 (View on PubMed)

Other Identifiers

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2018-62-K46

Identifier Type: -

Identifier Source: org_study_id

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