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NCT Number: NCT06709157

Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

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 .

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Key information

Conditions

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

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine

Sohag, 54345, Egypt

Location contact

Asmaa T Mostafa

CONTACT

Dina H Mohmad

CONTACT

Ebtisam M G

CONTACT

Mona M Abdelrahman

CONTACT

Noha S Shafik

CONTACT

[email protected]

0201067261504

Noha S Shafik

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic chest disease

Exclusion criteria

  • Patients with other respiratory or infectious diseases.

Treatment and study plan

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

Primary outcomes

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

    Time frame: December 2024- June 2025

    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

  2. The prevalence of tuberculosis in HIV patients

    Time frame: December 2024- June 2025

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Lecturer

CONTACT

Noha S Shafik, Lecturer

CONTACT

[email protected]

0201067261504

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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