Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT04085133
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Burden of Bronchiectasis in Tuberculous Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum by gene xpert'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-09-08', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study prevalence of bronchiectasis in TB patients by case per year.', 'timeFrame': 'One year', 'description': 'How many patients of TB will be diagnosed as abronchiectasis'}], 'secondaryOutcomes': [{'measure': 'To evaluate the burden of bronchiectasis in TB patients', 'timeFrame': 'one year', 'description': 'by frequency of need for hospital admission per year, need for outpatient clinical visits per month and frequency of need for antimicrobial therapy other than anti-tuberculous treatment per month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Tuberculoses']}, 'descriptionModule': {'briefSummary': 'Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree', 'detailedDescription': 'Bronchiectasis was described in the early 19th century by Laennec. Bronchiectasis is a chronic condition characterized by permanent and irreversible dilatation of the bronchial airways and impairment of mucociliary transport mechanism due to repeated infection and inflammation leading to colonization of organism and pooling of the mucus in the bronchial tree.\n\nThe prevalence of bronchiectasis is age-related and occurs in every age group and in the pre-antibiotic era . it most often began in childhood. Recent evidence shows that bronchiectasis disproportionately affects women and older individuals and will be contributing to increase in healthcare burden.\\[3\\] International data show an increase in the prevalence of bronchiectasis over recent years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any tuberculosis patients admited to assuit university hospital and assuit chest hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-patients were diagnosed to have tuberculosis by sputum culture and gene x pert.\n\n 2-patients were diagnosed to have bronchiectasis after lab and radiological examination as well as clinical score.\n\n 3- patients diagnosed as bronchiectasis after history of tuberculosis or anti Tuberculosis treatment with positive or negative tuberculous culture in the time of research.\n\nExclusion Criteria:\n\n* 1-patients presented with other Pulmonary diseases. 2-Chronic liver and renal disease . 3- Lung cancer and tumors. 4- patients were previously diagnosed as bronchiectasis .'}, 'identificationModule': {'nctId': 'NCT04085133', 'briefTitle': 'Prevalence and Burden of Bronchiectasis in Tuberculous Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence and Burden of Bronchiectasis in Tuberculous Patients', 'orgStudyIdInfo': {'id': '12345817'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gene Xpert Chest x ray and MSCT chest', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sputum sample for T.B will be done using gene expert device and chest xray and high resolution ct to evaluate bronchectasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut unviresty', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR.Ahmad Shaddad', 'investigatorFullName': 'Ahmad Shaddad', 'investigatorAffiliation': 'Assiut University'}}}}