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

Completed

• Conditions: Latent Tuberculosis Infection

• Registration Number: NCT01608685
• Lead Sponsor: Ligue Pulmonaire Genevoise

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-07-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-30
• Last Update Submitted: 2012-05-30
• Study First Posted: 2012-05-31
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• prior renal transplantation;
• age > 18;
• stable clinical condition

Exclusion Criteria

• hypersensitivity to tuberculin skin testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geneva University Hospital/Division of Nephrology; 🇨🇭 Geneva 11, Geneva, Switzerland