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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608685
First Posted: May 31, 2012
Last Update Posted: May 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean-Paul Janssens, Ligue Pulmonaire Genevoise
July 5, 2011
May 31, 2012
May 31, 2012
January 2010
December 2011   (Final data collection date for primary outcome measure)
  • Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection [ Time Frame: 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 [ Time Frame: 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
Same as current
No Changes Posted
Agreement between results of IGRA tests and TST in renal transplant recipients [ Time Frame: Up to 3 years ]
Agreement between results of IGRA testing and between each IGRA test and TST will be determined by computing kappa values
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Patients followed by the Division of Nephrology after renal transplantation, and undergoing routine annual check-ups, in stable clinical condition, aged above 18
Latent Tuberculosis Infection
Not Provided
Renal transplant recipients
Inclusion criteria: All renal transplant recipients followed by the Division of Nephrology aged above 18 years, and having accepted study protocol after informed consent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • hypersensitivity to tuberculin skin testing
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01608685
KH-2010
No
Not Provided
Not Provided
Jean-Paul Janssens, Ligue Pulmonaire Genevoise
Ligue Pulmonaire Genevoise
Not Provided
Principal Investigator: Karin Hadaya, MD Division of Nephrology/Geneva University Hospital
Ligue Pulmonaire Genevoise
May 2012