Prevalence of Latent Tuberculosis Infection Among Hemodialysis Patients

NCT ID: NCT07210970

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-20

Brief 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). 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.

Conditions

Latent Tuberculosis Infection; End Stage Renal Disease (ESRD); Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hemodialysis Patients

Adult patients undergoing regular hemodialysis at Sohag University Hospital who will be screened for latent tuberculosis infection.

Tuberculin Skin Test (TST)

Intervention Type: DIAGNOSTIC_TEST

Intradermal injection of 5 unit (0.1 mm) of purified protein derivative (PPD) with measurement of induration after 48-72 hours.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

-

Exclusion Criteria

• active TB patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Ibrahim

Fatma Ahmed Ibrahim

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma A Ibrahim, MSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Sohag University

Other Identifiers

Soh-Med--25-9-5MS

Identifier Type: -

Identifier Source: org_study_id