Detection of Latent Tuberculosis in Hemodialysis Patients

Chronic Renal Failure Clinical Trial

Official title:

Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695734
• Other study ID #: JJanssens 4
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: June 10, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis

Description:

This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged over 18

• Under hemodialysis for > 3 months

• End stage renal failure

Exclusion Criteria:

• Refusal to participate

• Prior tuberculin skin test > 15 mm or any adverse reaction to tuberculin skin test

Study Design

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Latent Tuberculosis
• Renal Insufficiency
• Tuberculosis

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva	Geneva 14

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection		cross-sectionnal	Yes
Secondary	Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays		cross-sectionnal	No