Clinical trial NCT03594032: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Non-tuberculous Mycobacterial
Keywords: bronchiectasis
NTM infections
Middle-aged and old women
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 216
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: NTM infection rates
timeFrame: 24 months afer enrolled participants
Secondary outcomes:
measure: clinical characteristics of patients with bronchiectasis comorbid NTM infections
timeFrame: 24 months afer enrolled participants
measure: microbiological characteristics of patients with bronchiectasis comorbid NTM infections
timeFrame: 24 months afer enrolled participants
measure: Drug resistance of NTM
timeFrame: 24 months afer enrolled participants
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ben Cao, MD
role: STUDY_CHAIR
References:
citation: 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.