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Not yet recruitingNCT06709157Updated Nov 29, 2024

Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients

An observational study in Tuberculosis, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
16 Years to 60 Years
Sex
All
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Study 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 .

Read the 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.

02

Conditions studied

  • Tuberculosis

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Keywords

  • HIV
  • immunocompromised
  • cytokines
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 200 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
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

Inclusion criteria

  • Patients with chronic chest disease

Exclusion criteria

Exclusion Criteria:

  • Patients with other respiratory or infectious diseases.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testP24 antigens and antibody

    estimation of antigens and antibodies to diagnose HIV

  • Diagnostic testzeihl - Nelsen stain

    staining sputum from patients with HIV to detect tubercle bacilli

  • Diagnostic testculture on Lowenstein jensen media

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

  • Diagnostic testMolecular detection of antibiotic resistance

    to see the pattern of antibiotic resistance of tubercle bacilli

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What researchers measure

Primary outcomes

  1. 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

    Time frame: December 2024- June 2025

  2. 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

    Time frame: December 2024- June 2025

07

Study locations

1 site
  • Faculty of medicine
    Sohag, 54345, Egypt
    • Noha S Shafik · Contact · Nohasaber@med.sohag.edu.eg · 0201067261504
    • Mona M Abdelrahman · Contact
    • Noha S Shafik · Contact
    • Ebtisam M G · Contact
    • Dina H Mohmad · Contact
    • Asmaa T Mostafa · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06709157
Lead sponsor
Sohag University
Responsible party
Noha Saber Shafik (lecturer of Medical Microbiology and Immunology, Sohag University) — Principal investigator
First posted
Nov 29, 2024
Start date
Dec 10, 2024 (estimated)
Primary completion
Dec 20, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Nov 29, 2024

Study contacts

Noha S Shafik, Lecturer
Contact
Nohasaber@med.sohag.edu.eg
0201067261504
Mona Lecturer
Contact
Noha S Shafik, Lecturer
principal investigator · Sohag university, Faculty of medicine
Asmaa T Mostafa, Lecturer
study chair · Sohag university, Faculty of Medicine
Ebtisam M Gad, Lecturer
study chair · Sohag university, Faculty of Medicine
Mona M Abdelrahman, Lecturer
study chair · Sohag university, Faculty of Medicine
Dina H Mohamed, Lecturer
study chair · Sohag university, Faculty of medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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