Detection of Latent Tuberculosis in Hemodialysis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00695734

Enrollment

Registered

2008-06-12

Start date

2007-01-31

Completion date

2008-01-31

Last updated

2008-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

hemodialysis, end stage renal failure, tuberculosis, latent tuberculosis infection, Patients under hemodialysis for end stage renal failure

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results