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Detection of Latent Tuberculosis in Hemodialysis Patients

Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
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: Observational Model: Case-Only, Time Perspective: 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
Last updated: June 10, 2008

Page last updated: August 23, 2015

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