Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- NTM infection rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Middle-aged and old women who are > or = 50 years of age
- •Patients meet the criteria of bronchiectasis
排除标准
- •Cystic fibrosis
- •After organ transplantation
- •Activity tumor (malignant solid tumor and blood system tumor)
- •Pulmonary interstitial fibrosis with bronchus dilation
- •Allergic bronchopulmonary aspergillosis
- •Diffuse panbronchiolitis
- •Patients refused to sign the informed consent
- •Patients unable to return sputum specimens
结局指标
主要结局
NTM infection rates
时间窗: 24 months afer enrolled participants
NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China
次要结局
- clinical characteristics of patients with bronchiectasis comorbid NTM infections(24 months afer enrolled participants)
- microbiological characteristics of patients with bronchiectasis comorbid NTM infections(24 months afer enrolled participants)
- Drug resistance of NTM(24 months afer enrolled participants)
研究者
Bin Cao
Clinical professor
Capital Medical University