Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tuberculosis (TB), End-Stage Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Interferon-gamma Release Assays, Symptom Screening and Chest Radiograph for Detection of Subclinical Tuberculosis of End-stage Kidney Disease and Kidney Transplant Recipients in Thailand
Overview
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
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.
Primary outcome measures
- 1.The number of participants with positive IGRAs among end-stage kidney disease and kidney transplant patients [Time frame: A prospective cohort study with following up period 2 years]
- 2. The number of participants with latent TB and active TB among end-stage kidney disease and kidney transplant patients during the 2-year follow-up defined by: [Time frame: A prospective cohort study with following up period 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Positive PPD test or a previously documented positive PPD
- Active pulmonary or extrapulmonary tuberculosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Thailand · 1 center
- Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University — Bangkok
Identifiers
NCT: NCT06700876 · NRCT9-5