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

NCT01608685 | Completed

• 1 other identifier: KH-2010
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Latent Tuberculosis Infection

Keywords

Tuberculosis; Latent tuberculosis infection; Immunosuppression; Renal transplant recipient

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Agreement between results of IGRA tests and TST in renal transplant recipients

  Up to 3 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• hypersensitivity to tuberculin skin testing

Sponsors & Collaborators

• Ligue Pulmonaire Genevoise: lead

Study Sites (1)

Geneva University Hospital/Division of Nephrology

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 19164327 BACKGROUND

• 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.

  PMID: 23694948 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Karin Hadaya, MD

  Division of Nephrology/Geneva University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: May 31, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

CH (1)