NCT07210970

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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)

Interventions

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

Hemodialysis Patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • active TB patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Latent TuberculosisKidney Failure, Chronic

Interventions

Tuberculin Test

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Fatma A Ibrahim, MSc

    Faculty of Medicine, Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fatma Ahmed Ibrahim

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 20, 2027

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. Only aggregated results will be presented in the thesis and any related publications.