A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Transplant
- Sponsor
- Asan Medical Center
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- development of tuberculosis
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.
Detailed Description
We evaluate the usefulness of a newly-developed T cell-based assay prior to undergoing immunosuppression in renal transplant recipients. Among all renal transplant recipients, patients with negative tuberculin skin test and no other indications for latent tuberculosis infection will be enrolled in this study. We will exam T-SPOT.TB test in these patients, and observe the developement of tuberculosis within 1 to 2 years after the transplantation. The results of T-SPOT.TB will be blinded to the investigators.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 16 or more
- •Negative tuberculin skin test (induration less than 10 mm)
Exclusion Criteria
- •Recent contact of patients with active pulmonary tuberculosis
- •Suspected active tuberculosis
Outcomes
Primary Outcomes
development of tuberculosis
Time Frame: within 2 years after transplantation
Secondary Outcomes
- all cause mortality(within 2 years after transplantation)