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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Paul Janssens, Ligue Pulmonaire Genevoise
ClinicalTrials.gov Identifier:
NCT01608685
First received: July 5, 2011
Last updated: May 30, 2012
Last verified: May 2012

July 5, 2011
May 30, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Complete list of historical versions of study NCT01608685 on ClinicalTrials.gov Archive Site
Agreement between results of IGRA tests and TST in renal transplant recipients [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01608685
KH-2010
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP