Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT03594032
Status:
UNKNOWN
Last Update Posted:
2020-01-03
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NTM infection rates', 'timeFrame': '24 months afer enrolled participants', 'description': 'NTM infection rates in Middle-aged and old women patients with bronchiectasis in northern China'}], 'secondaryOutcomes': [{'measure': 'clinical characteristics of patients with bronchiectasis comorbid NTM infections', 'timeFrame': '24 months afer enrolled participants', 'description': 'clinical manifestations of patients with bronchiectasis comorbid NTM infections'}, {'measure': 'microbiological characteristics of patients with bronchiectasis comorbid NTM infections', 'timeFrame': '24 months afer enrolled participants', 'description': 'microbiological characteristics of patients with bronchiectasis comorbid NTM'}, {'measure': 'Drug resistance of NTM', 'timeFrame': '24 months afer enrolled participants', 'description': 'drug susceptibility testing outcomes of nontuberculous mycobacteria from sputum samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis', 'NTM infections', 'Middle-aged and old women'], 'conditions': ['Bronchiectasis', 'Non-tuberculous Mycobacterial']}, 'referencesModule': {'references': [{'pmid': '34872515', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '216 patients with bronchiectasis who meet the below inclusion criteria will be re cruited in China-Japan Friendship Hospital in Beijing,China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Middle-aged and old women who are \\> or = 50 years of age\n2. Patients meet the criteria of bronchiectasis\n\nExclusion Criteria:\n\n1. Cystic fibrosis\n2. After organ transplantation\n3. Activity tumor (malignant solid tumor and blood system tumor)\n4. Pulmonary interstitial fibrosis with bronchus dilation\n5. Allergic bronchopulmonary aspergillosis\n6. Diffuse panbronchiolitis\n7. Patients refused to sign the informed consent\n8. Patients unable to return sputum specimens'}, 'identificationModule': {'nctId': 'NCT03594032', 'briefTitle': 'Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Prevalence and Clinical Characteristics of Patients With Bronchiectasis With Comorbid Nontuberculous Mycobacteria Among Middle-aged and Old Women', 'orgStudyIdInfo': {'id': '2018-62-K46'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Cao, MD', 'role': 'CONTACT', 'email': 'caobin_ben@163.com', 'phone': '86-010-84206264'}, {'name': 'Hongjun Yin, MD', 'role': 'CONTACT', 'email': 'yhjh1101@163.com', 'phone': '86 13621089726'}, {'name': 'Bin Cao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongjun Yin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongjun Yin, MD', 'role': 'CONTACT', 'email': 'yhjh1101@163.com', 'phone': '86 13621089726', 'phoneExt': '861084206250'}, {'name': 'Ben Cao, MD', 'role': 'CONTACT', 'email': 'caobin_ben@163.com', 'phone': '86-010-84206264', 'phoneExt': '8601084206264'}], 'overallOfficials': [{'name': 'Ben Cao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bin Cao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Bin Cao', 'investigatorAffiliation': 'Capital Medical University'}}}}