Detection of Latent Tuberculosis in Hemodialysis Patients

Completed

• Conditions: Chronic Renal Failure

• Registration Number: NCT00695734
• Lead Sponsor: University Hospital, Geneva

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Last Update Submitted: 2008-06-10
• Study First Posted: 2008-06-12
• Last Update Posted: 2008-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection	cross-sectionnal

Secondary Outcome Measures

Name	Time	Method
Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays	cross-sectionnal

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Geneva, Geneva 14, Switzerland