Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis; End Stage Renal Disease (ESRD); Latent Tuberculosis Infection
• Intervention / Treatment: Diagnostic test: Tuberculin Skin Test (TST)

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 Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

Age ≥ 18 years Patients on regular hemodialysis Able and willing to provide informed consent

-

Exclusion Criteria:

• active TB patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemodialysis Patients; Adult patients undergoing regular hemodialysis at Sohag University Hospital who will be screened for latent tuberculosis infection.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of latent tuberculosis infection among hemodialysis patients.	Percentage of patients with positive tuberculin skin test (defined as induration ≥10 mm).	Within 72 hours after TST administration.

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Fatma A Ibrahim, MSc, Faculty of Medicine, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: September 30, 2025
• First Posted (Estimated): October 7, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Latent Infection; Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Infections; Renal Insufficiency; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Renal Insufficiency, Chronic; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Latent Tuberculosis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Skin Tests; Tuberculin Test
• Other Study ID Numbers: Soh-Med--25-9-5MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. Only aggregated results will be presented in the thesis and any related publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No