Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

NCT06709157 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-24-08--05PD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Tuberculosis

Keywords

HIV; immunocompromised; cytokines

Outcome Measures

Primary Outcomes (2)

• The Prevalance of tubercuolsis in immunocompetent patients suffereing from chronic chest problems

  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

  December 2024- June 2025

• The prevalence of tuberculosis in HIV patients

  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

  December 2024- June 2025

Interventions

P24 antigens and antibody DIAGNOSTIC_TEST

estimation of antigens and antibodies to diagnose HIV

zeihl - Nelsen stain DIAGNOSTIC_TEST

staining sputum from patients with HIV to detect tubercle bacilli

culture on Lowenstein jensen media DIAGNOSTIC_TEST

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

Molecular detection of antibiotic resistance DIAGNOSTIC_TEST

to see the pattern of antibiotic resistance of tubercle bacilli

Eligibility Criteria

• Age: 16 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with chronic chest disease

You may not qualify if:

• Patients with other respiratory or infectious diseases.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine

Sohag, 54345, Egypt

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Noha S Shafik, Lecturer

  Sohag university, Faculty of medicine

  PRINCIPAL INVESTIGATOR

• Asmaa T Mostafa, Lecturer

  Sohag university, Faculty of Medicine

  STUDY CHAIR

• Ebtisam M Gad, Lecturer

  Sohag university, Faculty of Medicine

  STUDY CHAIR

• Mona M Abdelrahman, Lecturer

  Sohag university, Faculty of Medicine

  STUDY CHAIR

• Dina H Mohamed, Lecturer

  Sohag university, Faculty of medicine

  STUDY CHAIR

Central Study Contacts

Noha S Shafik, Lecturer

CONTACT

0201067261504; Nohasaber@med.sohag.edu.eg

Mona Lecturer

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Medical Microbiology and Immunology

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 29, 2024
• Study Start: December 10, 2024
• Primary Completion: December 20, 2024
• Study Completion: June 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)