Detection of Latent Tuberculosis in Hemodialysis Patients
Information source: University Hospital, Geneva
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Renal Failure
Phase: N/A
Status: Completed
Sponsored by: University Hospital, Geneva Official(s) and/or principal investigator(s):
Jean-Paul Janssens, MD, Principal Investigator, Affiliation: Geneva University Hospital
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
Clinical Details
Official title: Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients
Study design: Case-Only, Cross-Sectional
Primary outcome: Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection
Secondary outcome: Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Geneva University Hospital, Geneva, Geneva 14 1211, Switzerland
Additional Information
Starting date: January 2007
Ending date: January 2008
Last updated: June 10, 2008
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