Latent Tuberculosis Infection in Renal Transplant Recipients

A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Renal Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00682045

Enrollment

240

Registered

2008-05-21

Start date

2008-06-30

Completion date

2010-05-31

Last updated

2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant

Keywords

tuberculosis, transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
development of tuberculosis	within 2 years after transplantation

Secondary

Measure	Time frame
all cause mortality	within 2 years after transplantation

Countries

South Korea

Outcome results