Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients

Interferon Gamma Release Assays Versus Tuberculin Skin Testing for the Detection of Latent Tuberculosis Infection in Renal Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01608685

Enrollment

205

Registered

2012-05-31

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2012-05-31

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

Conditions

Latent Tuberculosis Infection

Keywords

Tuberculosis, Latent tuberculosis infection, Immunosuppression, Renal transplant recipient

Brief summary

Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV. The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.

Detailed description

In a recent study (Triverio PA et al. Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in haemodialysis patients. Nephrol Dial Transplant 2009; 24: 1952-6), the investigators had compared 2 IGRAs (T-SPOT.TB and Quantiferon Gold) with the TST and shown that one IGRA was clearly more sensitive than the TST but that both tests had a very low sensitivity for detecting prior TB. This study applies the same protocol to renal transplant recipients undergoing routine annual check-up visits: questionnaire with detailed collection of risk factors for latent tuberculosis infection (LTBI), history of prior contact with tuberculosis (TB), BCG (Bacille of Calmette and Guerin vaccine), prior TB or LTBI, treatment for TB or LTBI, analysis of chest X-ray for signs of prior TB, on-going treatment, level of immunosuppression (CD4 lymphocytes), simultaneous blood sampling for T-SPOT.TB and Quantiferon Gold, and tuberculin skin testing.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* prior renal transplantation; * age \> 18; * stable clinical condition

Exclusion criteria

* hypersensitivity to tuberculin skin testing

Design outcomes

Primary

Measure	Time frame	Description
Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection	Up to 3 years	Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and results of QuantiFERON-Gold-in-tube is computed
Agreement between results of T-SPOT.TB and probability of latent tuberculosis infection	Up to 3 years	Agreement between probability of latent tuberculosis infection - established on the basis of a questionnaire and chest X-ray - and result of T-SPOT.TB is computed

Secondary

Measure	Time frame	Description
Agreement between results of IGRA tests and TST in renal transplant recipients	Up to 3 years	Agreement between results of IGRA testing and between each IGRA test and TST will be determined by computing kappa values

Countries

Switzerland

Outcome results