Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT

NCT ID: NCT06700876

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-06

Study Completion Date

2027-06-30

Brief Summary

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This is an observational study among approximately 160 end-stage renal disease patients on renal replacement therapy and post-living donor or deceased donor kidney transplant recipients. Investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

Detailed Description

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Patients with chronic kidney disease and end-stage kidney disease (ESKD) are at risk of developing tuberculosis and are often delayed in diagnosis. Herein, investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

Conditions

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Tuberculosis (TB) End-Stage Kidney Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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160 End-stage renal disease patients

End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation aged more than or equal 18 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation
2. Aged more than or equal 18 years

Exclusion Criteria

1. Positive PPD test or a previously documented positive PPD
2. Active pulmonary or extrapulmonary tuberculosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Punnee Pitisuttithum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Punnee Pitisuttithum, Prof. E.

Role: STUDY_CHAIR

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Locations

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Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Tanaya Siripoon, M.D.

Role: CONTACT

6626435599

Punnee Pitisuttithum, Prof. E.

Role: CONTACT

6626435599

Other Identifiers

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NRCT9-5

Identifier Type: -

Identifier Source: org_study_id

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