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Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

NCT ID: NCT06709157

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-06-01

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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P24 antigens and antibody

estimation of antigens and antibodies to diagnose HIV

Intervention Type DIAGNOSTIC_TEST

zeihl - Nelsen stain

staining sputum from patients with HIV to detect tubercle bacilli

Intervention Type DIAGNOSTIC_TEST

culture on Lowenstein jensen media

spenciem will be inoculated on LJ media and kept for 2-8 weeks, to see small white colonies

Intervention Type DIAGNOSTIC_TEST

Molecular detection of antibiotic resistance

to see the pattern of antibiotic resistance of tubercle bacilli

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic chest disease

Exclusion Criteria

* Patients with other respiratory or infectious diseases.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Noha Saber Shafik

lecturer of Medical Microbiology and Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha S Shafik, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Sohag university, Faculty of medicine

Asmaa T Mostafa, Lecturer

Role: STUDY_CHAIR

Sohag university, Faculty of Medicine

Ebtisam M Gad, Lecturer

Role: STUDY_CHAIR

Sohag university, Faculty of Medicine

Mona M Abdelrahman, Lecturer

Role: STUDY_CHAIR

Sohag university, Faculty of Medicine

Dina H Mohamed, Lecturer

Role: STUDY_CHAIR

Sohag university, Faculty of medicine

Locations

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Faculty of medicine

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Noha S Shafik, Lecturer

Role: CONTACT

[email protected]
0201067261504

Mona Lecturer

Role: CONTACT

Facility Contacts

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Noha S Shafik

Role: primary

[email protected]
0201067261504

Mona M Abdelrahman

Role: backup

Noha S Shafik

Role: backup

Ebtisam M G

Role: backup

Dina H Mohmad

Role: backup

Asmaa T Mostafa

Role: backup

Other Identifiers

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Soh-Med-24-08--05PD

Identifier Type: -

Identifier Source: org_study_id