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Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria

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ClinicalTrials.gov Identifier: NCT03594032
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bin Cao, Capital Medical University

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.

Condition or disease
Bronchiectasis Non-tuberculous Mycobacterial

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 May 2018


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Study Type : Observational
Estimated Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. NTM infection rates [ Time Frame: 6 months afer enrolled participants ]
    NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China


Secondary Outcome Measures :
  1. clinical characteristics of patients with bronchiectasis comorbid NTM infections [ Time Frame: 6 months afer enrolled participants ]
    clinical manifestations of patients with bronchiectasis comorbid NTM infections

  2. microbiological characteristics of patients with bronchiectasis comorbid NTM infections [ Time Frame: 6 months afer enrolled participants ]
    microbiological characteristics of patients with bronchiectasis comorbid NTM

  3. Drug resistance of NTM [ Time Frame: 6 months afer enrolled participants ]
    drug susceptibility testing outcomes of nontuberculous mycobacteria from sputum samples



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Middle-aged and old women who are > or = 50 years of age
  2. Patients meet the criteria of bronchiectasis
  3. Antibiotics had not been used for four weeks before recruiting

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. Patients refused to sign the informed consent
  6. Patients unable to return sputum specimens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594032


Contacts
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Contact: Hongjun Yin, MD 86 13621089726 ext 861084206250 yhjh1101@163.com
Contact: Ben Cao, MD 86-010-84206264 ext 8601084206264 caobin_ben@163.com

Locations
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China
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 100029
Contact: Bin Cao, MD    86-010-84206264    caobin_ben@163.com   
Contact: Hongjun Yin, MD    86 13621089726    yhjh1101@163.com   
Principal Investigator: Bin Cao, MD         
Principal Investigator: Hongjun Yin, MD         
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 100029
Contact: Bin Cao, MD    8601084206264 ext 8601084206264    caobin_ben@163.com   
Contact: Hongjun Yin, MD    8601084206264 ext 8601084206264    yhjh1101@163.com   
Sponsors and Collaborators
Bin Cao
Investigators
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Study Chair: Ben Cao, MD China-Japan Friendship Hospital

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Responsible Party: Bin Cao, Clinical professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03594032     History of Changes
Other Study ID Numbers: 2018-62-K46
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bin Cao, Capital Medical University:
bronchiectasis
NTM infections
Middle-aged and old women

Additional relevant MeSH terms:
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Bronchiectasis
Mycobacterium Infections
Bronchial Diseases
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections