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

Latent Tuberculosis Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608685
• Other study ID #: KH-2010
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: May 30, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Ligue Pulmonaire Genevoise
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• prior renal transplantation;

• age > 18;

• stable clinical condition

Exclusion Criteria:

• hypersensitivity to tuberculin skin testing

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital/Division of Nephrology	Geneva 11	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Triverio PA, Bridevaux PO, Roux-Lombard P, Niksic L, Rochat T, Martin PY, Saudan P, Janssens JP. Interferon-gamma release assays versus tuberculin skin testing for detection of latent tuberculosis in chronic haemodialysis patients. Nephrol Dial Transplant. 2009 Jun;24(6):1952-6. doi: 10.1093/ndt/gfn748. Epub 2009 Jan 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between results of QuantiFERON-Gold-in-tube and probability of latent tuberculosis infection	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	Up to 3 years	No
Primary	Agreement between results of T-SPOT.TB and probability of latent tuberculosis infection	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	Up to 3 years	No
Secondary	Agreement between results of IGRA tests and TST in renal transplant recipients	Agreement between results of IGRA testing and between each IGRA test and TST will be determined by computing kappa values	Up to 3 years	No