NCT03594032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

July 11, 2018

Last Update Submit

December 31, 2019

Conditions

Keywords

bronchiectasisNTM infectionsMiddle-aged and old women

Outcome Measures

Primary Outcomes (1)

  • NTM infection rates

    NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China

    24 months afer enrolled participants

Secondary Outcomes (3)

  • 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

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Middle-aged and old women who are \> or = 50 years of age
  • Patients meet the criteria of bronchiectasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, 100029, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Ben Cao, MD

    China-Japan Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

August 14, 2018

Primary Completion

December 1, 2020

Study Completion

August 1, 2021

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations