Latent Tuberculosis Infection in Renal Transplant Recipients

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.

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Key information

Conditions

Renal Transplant Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

development of tuberculosis

Time frame: within 2 years after transplantation

Secondary outcomes

all cause mortality

Time frame: within 2 years after transplantation

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: May 21, 2008
Registry last updated: Jun 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed