Latent Tuberculosis InfectionNCT07210970
Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients
An observational study of Latent Tuberculosis Infection and End Stage Renal Disease (ESRD), run by Sohag University.
Trial summary
This observational cross-sectional study aims to determine the prevalence of latent tuberculosis infection (LTBI) among patients undergoing regular hemodialysis at Sohag University Hospital, using the tuberculin skin test (TST). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Latent Tuberculosis Infection, End Stage Renal Disease (ESRD), Hemodialysis
- What is being tested?
- Tuberculin Skin Test (TST)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 20 Dec 2027
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing regular hemodialysis at Sohag University Hospital. The study will include patients aged 18 years and older who are clinically stable and able to undergo tuberculin skin testing
Who may be able to join
- Age ≥ 18 years Patients on regular hemodialysis Able and willing to provide informed consent
- -
Who cannot join
- active TB patients
About this study
Official title: Study of The Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients Using Tuberculin Skin Test at Sohag University Hospital
This observational cross-sectional study aims to determine the prevalence of latent tuberculosis infection (LTBI) among patients undergoing regular hemodialysis at Sohag University Hospital, using the tuberculin skin test (TST). Identifying the burden of LTBI in this high-risk population will help guide early detection and preventive strategies
Read the detailed description
Patients receiving chronic hemodialysis are at increased risk of developing tuberculosis due to impaired immune function and frequent exposure to healthcare environments. Latent tuberculosis infection (LTBI) is particularly concerning in this population as it may progress to active disease, leading to increased morbidity and mortality. Early detection of LTBI among hemodialysis patients is essential to reduce this risk.
This cross-sectional study will be conducted at Sohag University Hospital. Two step tuberculin skin test (TST) will be administered to eligible adult patients undergoing regular hemodialysis, the first injection sitewill be examined between 48to 72 hours, and if negative, asecond booster injection will be given 1 to 2 weeks later. The prevalence of LTBI will be assessed by calculating the percentage of patients with a positive TST result (induration ≥10 mm ). Secondary analyses will examine associations between TST positivity and demographic or clinical variables, including age, sex, duration of dialysis, and comorbidities. The results are expected to contribute to local data on the burden of LTBI and to support preventive healthcare strategies in this vulnerable group.
- Being tested
- Tuberculin Skin Test (TST)
- Medical subject headings
- Latent Tuberculosis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin Skin Test (TST)Diagnostic test
Intradermal injection of 5 unit (0.1 mm) of purified protein derivative (PPD) with measurement of induration after 48-72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | Adult patients undergoing regular hemodialysis at Sohag University Hospital who will be screened for latent tuberculosis infection. Receives: Diagnostic Test: Tuberculin Skin Test (TST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of latent tuberculosis infection among hemodialysis patients.
Percentage of patients with positive tuberculin skin test (defined as induration ≥10 mm).
Measured: Within 72 hours after TST administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Ibrahim, Sohag University
- Investigators
- Fatma A Ibrahim, MSc, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210970
- Sponsor's protocol ID
- Soh-Med--25-9-5MS
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Only aggregated results will be presented in the thesis and any related publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of The Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients Using Tuberculin Skin Test at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT07210970
- Acronym / sponsor ID
- Soh-Med--25-9-5MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 7 Oct 2025 (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.
This observational cross-sectional study aims to determine the prevalence of latent tuberculosis infection (LTBI) among patients undergoing regular hemodialysis at Sohag University Hospital, using the tuberculin skin test (TST). Identifying the burden of LTBI in this high-risk population will help guide early detection and preventive strategies
Detailed description
Patients receiving chronic hemodialysis are at increased risk of developing tuberculosis due to impaired immune function and frequent exposure to healthcare environments. Latent tuberculosis infection (LTBI) is particularly concerning in this population as it may progress to active disease, leading to increased morbidity and mortality. Early detection of LTBI among hemodialysis patients is essential to reduce this risk.
This cross-sectional study will be conducted at Sohag University Hospital. Two step tuberculin skin test (TST) will be administered to eligible adult patients undergoing regular hemodialysis, the first injection sitewill be examined between 48to 72 hours, and if negative, asecond booster injection will be given 1 to 2 weeks later. The prevalence of LTBI will be assessed by calculating the percentage of patients with a positive TST result (induration ≥10 mm ). Secondary analyses will examine associations between TST positivity and demographic or clinical variables, including age, sex, duration of dialysis, and comorbidities. The results are expected to contribute to local data on the burden of LTBI and to support preventive healthcare strategies in this vulnerable group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients | – | Diagnostic Test: Tuberculin Skin Test (TST)Adult patients undergoing regular hemodialysis at Sohag University Hospital who will be screened for latent tuberculosis infection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing regular hemodialysis at Sohag University Hospital. The study will include patients aged 18 years and older who are clinically stable and able to undergo tuberculin skin testing
Key inclusion criteria (2 listed)
- Age ≥ 18 years Patients on regular hemodialysis Able and willing to provide informed consent
- -
Key exclusion criteria (1 listed)
- active TB patients
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 |
|---|---|---|
| Tuberculin Skin Test (TST)Intradermal injection of 5 unit (0.1 mm) of purified protein derivative (PPD) with measurement of induration after 48-72 hours. | Diagnostic test | Hemodialysis Patients |
Primary outcome
Prevalence of latent tuberculosis infection among hemodialysis patients.
Time frame: Within 72 hours after TST administration.
Percentage of patients with positive tuberculin skin test (defined as induration ≥10 mm).
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 7 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Only aggregated results will be presented in the thesis and any related publications.
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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.
Fatma A Ibrahim, MSc principal investigator
Faculty of Medicine, Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis Infection and End Stage Renal Disease (ESRD), run by Sohag University.
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 2 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of latent tuberculosis infection among hemodialysis patients. (time frame: Within 72 hours after TST administration.). 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 7 Oct 2025.