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NCT Number: NCT01608685

Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test 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.

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Key information

Conditions

Latent Tuberculosis Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital/Division of Nephrology

Geneva, Canton of Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • hypersensitivity to tuberculin skin testing

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ligue Pulmonaire Genevoise

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 31, 2012
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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