BronchiectasisNCT03594032
Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria
An observational study of Bronchiectasis and Non-tuberculous Mycobacterial, run by Bin Cao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Bronchiectasis, Non-tuberculous Mycobacterial
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2018to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 216 patients with bronchiectasis who meet the below inclusion criteria will be re cruited in China-Japan Friendship Hospital in Beijing,China.
Who may be able to join
- Middle-aged and old women who are > or = 50 years of age
- Patients meet the criteria of bronchiectasis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Bin Cao, MD, 86-010-84206264, caobin_ben@163.com
Hongjun Yin, MD, 86 13621089726, yhjh1101@163.com
About this study
Official title: Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women
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.
Read the 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.
- Conditions
- Bronchiectasis, Non-tuberculous Mycobacterial
- Keywords
- bronchiectasis, NTM infections, Middle-aged and old women
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
NTM infection rates
NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China
Measured: 24 months afer enrolled participants
Secondary outcomes (3)
clinical characteristics of patients with bronchiectasis comorbid NTM infections
clinical manifestations of patients with bronchiectasis comorbid NTM infections
Measured: 24 months afer enrolled participants
microbiological characteristics of patients with bronchiectasis comorbid NTM infections
microbiological characteristics of patients with bronchiectasis comorbid NTM
Measured: 24 months afer enrolled participants
Drug resistance of NTM
drug susceptibility testing outcomes of nontuberculous mycobacteria from sputum samples
Measured: 24 months afer enrolled participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start14 Aug 2018
- Primary completionDec 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
- Investigators
- Ben Cao, MD, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594032
- Sponsor's protocol ID
- 2018-62-K46
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2018
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34872515
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women
- ClinicalTrials.gov ID
- NCT03594032
- Acronym / sponsor ID
- 2018-62-K46
- Conditions
- Bronchiectasis, Non-tuberculous Mycobacterial
- Keywords
- bronchiectasis, NTM infections, Middle-aged and old women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 216 patients with bronchiectasis who meet the below inclusion criteria will be re cruited in China-Japan Friendship Hospital in Beijing,China.
Key inclusion criteria (2 listed)
- Middle-aged and old women who are > or = 50 years of age
- Patients meet the criteria of bronchiectasis
Key exclusion criteria (8 listed)
- Cystic fibrosis
- After organ transplantation
- Activity tumor (malignant solid tumor and blood system tumor)
- Pulmonary interstitial fibrosis with bronchus dilation
- Allergic bronchopulmonary aspergillosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NTM infection rates
Time frame: 24 months afer enrolled participants
NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China
3 secondary outcomes
clinical characteristics of patients with bronchiectasis comorbid NTM infections
Time frame: 24 months afer enrolled participants
microbiological characteristics of patients with bronchiectasis comorbid NTM infections
Time frame: 24 months afer enrolled participants
Drug resistance of NTM
Time frame: 24 months afer enrolled participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Derived from this study: PubMed 34872515Yin 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.
- Individual participant dataSharing planned: Undecided
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Cao, MD study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis and Non-tuberculous Mycobacterial, run by Bin Cao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjun Yin, MD (86 13621089726 ext. 861084206250, yhjh1101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NTM infection rates (time frame: 24 months afer enrolled participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.