Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

November 27, 2024 updated by: Noha Saber Shafik, Sohag University
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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mona Lecturer

Study Locations

  • Egypt
      • Sohag, Egypt, 54345
        • Faculty of medicine
        • Contact:
        • Contact:
          • Mona M Abdelrahman
        • Contact:
          • Noha S Shafik
        • Contact:
          • Ebtisam M G
        • Contact:
          • Dina H Mohmad
        • Contact:
          • Asmaa T Mostafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • Patients with chronic chest disease

Exclusion Criteria:

  • Patients with other respiratory or infectious diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
December 2024- June 2025
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
December 2024- June 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Noha S Shafik, Lecturer, Sohag University, Faculty of Medicine
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2024

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-08--05PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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