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
  Purpose

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.


Condition
Latent Tuberculosis Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Interferon Gamma Release Assays Versus Tuberculin Skin Testing for the Detection of Latent Tuberculosis Infection in Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Ligue Pulmonaire Genevoise:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 205
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients followed by the Division of Nephrology after renal transplantation, and undergoing routine annual check-ups, in stable clinical condition, aged above 18

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hypersensitivity to tuberculin skin testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608685

Locations
Switzerland
Geneva University Hospital/Division of Nephrology
Geneva 11, Geneva, Switzerland, 1211
Sponsors and Collaborators
Ligue Pulmonaire Genevoise
Investigators
Principal Investigator: Karin Hadaya, MD Division of Nephrology/Geneva University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Paul Janssens, Associate Professor, Ligue Pulmonaire Genevoise
ClinicalTrials.gov Identifier: NCT01608685     History of Changes
Other Study ID Numbers: KH-2010
Study First Received: July 5, 2011
Last Updated: May 30, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Ligue Pulmonaire Genevoise:
Tuberculosis
Latent tuberculosis infection
Immunosuppression
Renal transplant recipient

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014