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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Latent Tuberculosis Infection

Keywords

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Tuberculosis Latent tuberculosis infection Immunosuppression Renal transplant recipient

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* prior renal transplantation;
* age \> 18;
* stable clinical condition

Exclusion Criteria

* hypersensitivity to tuberculin skin testing

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jean-Paul Janssens

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karin Hadaya, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology/Geneva University Hospital

Locations

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Geneva University Hospital/Division of Nephrology

Geneva, Canton of Geneva, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND

PMID: 19164327 (View on PubMed)

Hadaya K, Bridevaux PO, Roux-Lombard P, Delort A, Saudan P, Martin PY, Janssens JP. Contribution of interferon-gamma release assays (IGRAs) to the diagnosis of latent tuberculosis infection after renal transplantation. Transplantation. 2013 Jun 27;95(12):1485-90. doi: 10.1097/TP.0b013e3182907073.

Reference Type DERIVED

PMID: 23694948 (View on PubMed)

Other Identifiers

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KH-2010

Identifier Type: -

Identifier Source: org_study_id