Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
Study NCT ID:
NCT06709157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Prevalance of tubercuolsis in immunocompetent patients suffereing from chronic chest problems', 'timeFrame': 'December 2024- June 2025', 'description': 'Patients suffering from chronic chest problems will be screened for presence of TB bacilli using chest X-ray, sputum smear, culture on LJ media, detection of DNA of TB bacilli using PCR'}, {'measure': 'The prevalence of tuberculosis in HIV patients', 'timeFrame': 'December 2024- June 2025', 'description': 'Detection of tubercle bacilli in HIV positive patients , these patients will be screened for presence of TB bacilli using chest X-ray, sputum smear, culture on LJ media, detection of DNA of TB bacilli using PCR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'immunocompromised', 'cytokines'], 'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Tuberculosis (TB) is caused by Mycobacterium tuberculosis and is one of the top 10 causes of mortality worldwide. It is estimated that in 2017, 10 million people were infected with TB, and 1.6 million died from the disease, including 0.3 million people with human immunodeficiency virus (HIV) infection . TB remains the primary killer of HIV-positive individuals. TB incidence is falling at about 2% per year . Airborne transmission of M. tuberculosis typically causes TB infection in both immunocompetent and immunocompromised hosts and the disease is symptomatic and contagious .', 'detailedDescription': 'TB and HIV infections are strictly linked together. TB is the most common opportunistic infection and causes high morbidity rate among people living with HIV. Because of the decrease in cell-mediated immunity, HIV alters the pathogenesis of TB, thereby expressively increasing the risk of TB in HIV-positive patients and eventually leading to more severe complications and forms of TB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be conducted on 100-200 patients with pulmonary and extra pulmonary TB attending Sohag University Hospital during the period from September 2024 to August 2025', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic chest disease\n\nExclusion Criteria:\n\n* Patients with other respiratory or infectious diseases.'}, 'identificationModule': {'nctId': 'NCT06709157', 'briefTitle': 'Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-24-08--05PD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'P24 antigens and antibody', 'type': 'DIAGNOSTIC_TEST', 'description': 'estimation of antigens and antibodies to diagnose HIV'}, {'name': 'zeihl - Nelsen stain', 'type': 'DIAGNOSTIC_TEST', 'description': 'staining sputum from patients with HIV to detect tubercle bacilli'}, {'name': 'culture on Lowenstein jensen media', 'type': 'DIAGNOSTIC_TEST', 'description': 'spenciem will be inoculated on LJ media and kept for 2-8 weeks, to see small white colonies'}, {'name': 'Molecular detection of antibiotic resistance', 'type': 'DIAGNOSTIC_TEST', 'description': 'to see the pattern of antibiotic resistance of tubercle bacilli'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54345', 'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Noha S Shafik', 'role': 'CONTACT', 'email': 'Nohasaber@med.sohag.edu.eg', 'phone': '0201067261504'}, {'name': 'Mona M Abdelrahman', 'role': 'CONTACT'}, {'name': 'Noha S Shafik', 'role': 'CONTACT'}, {'name': 'Ebtisam M G', 'role': 'CONTACT'}, {'name': 'Dina H Mohmad', 'role': 'CONTACT'}, {'name': 'Asmaa T Mostafa', 'role': 'CONTACT'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Noha S Shafik, Lecturer', 'role': 'CONTACT', 'email': 'Nohasaber@med.sohag.edu.eg', 'phone': '0201067261504'}, {'name': 'Mona Lecturer', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Noha S Shafik, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag university, Faculty of medicine'}, {'name': 'Asmaa T Mostafa, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag university, Faculty of Medicine'}, {'name': 'Ebtisam M Gad, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag university, Faculty of Medicine'}, {'name': 'Mona M Abdelrahman, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag university, Faculty of Medicine'}, {'name': 'Dina H Mohamed, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag university, Faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of Medical Microbiology and Immunology', 'investigatorFullName': 'Noha Saber Shafik', 'investigatorAffiliation': 'Sohag University'}}}}