TuberculosisNCT06709157
Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients
An observational study of Tuberculosis, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- P24 antigens and antibody, zeihl - Nelsen stain and culture on Lowenstein jensen media
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Patients with chronic chest disease
Who cannot join
- Patients with other respiratory or infectious diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mona Lecturer contact
Egypt1 site
Faculty of medicine
Sohag, 54345
Noha S Shafik, 0201067261504, Nohasaber@med.sohag.edu.eg
Mona M Abdelrahman
About this study
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.
- Conditions
- Tuberculosis
- Being tested
- P24 antigens and antibody, zeihl - Nelsen stain, culture on Lowenstein jensen media, Molecular detection of antibiotic resistance
- Keywords
- HIV, immunocompromised, cytokines
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P24 antigens and antibodyDiagnostic test
estimation of antigens and antibodies to diagnose HIV
zeihl - Nelsen stainDiagnostic test
staining sputum from patients with HIV to detect tubercle bacilli
culture on Lowenstein jensen mediaDiagnostic test
spenciem will be inoculated on LJ media and kept for 2-8 weeks, to see small white colonies
Molecular detection of antibiotic resistanceDiagnostic test
to see the pattern of antibiotic resistance of tubercle bacilli
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: December 2024- June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start10 Dec 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- Noha S Shafik, Lecturer, Principal investigator, Sohag university, Faculty of medicineAsmaa T Mostafa, Lecturer, Study chair, Sohag university, Faculty of MedicineEbtisam M Gad, Lecturer, Study chair, Sohag university, Faculty of MedicineMona M Abdelrahman, Lecturer, Study chair, Sohag university, Faculty of MedicineDina H Mohamed, Lecturer, Study chair, Sohag university, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709157
- Sponsor's protocol ID
- Soh-Med-24-08--05PD
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunocompetent Versus Immunocompromised Tuberculosis (TB) Patients
- ClinicalTrials.gov ID
- NCT06709157
- Acronym / sponsor ID
- Soh-Med-24-08--05PD
- Conditions
- Tuberculosis
- Keywords
- HIV, immunocompromised, cytokines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Patients with chronic chest disease
Key exclusion criteria (1 listed)
- Patients with other respiratory or infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P24 antigens and antibodyestimation of antigens and antibodies to diagnose HIV | Diagnostic test | – |
| zeihl - Nelsen stainstaining sputum from patients with HIV to detect tubercle bacilli | Diagnostic test | – |
| culture on Lowenstein jensen mediaspenciem will be inoculated on LJ media and kept for 2-8 weeks, to see small white colonies | Diagnostic test | – |
| Molecular detection of antibiotic resistanceto see the pattern of antibiotic resistance of tubercle bacilli | Diagnostic test | – |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha S Shafik, Lecturer (0201067261504, Nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalance of tubercuolsis in immunocompetent patients suffereing from chronic chest problems (time frame: December 2024- June 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.