Detection of Latent Tuberculosis in Hemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00695734
First received: June 10, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 10, 2008
June 10, 2008
January 2007
January 2008   (final data collection date for primary outcome measure)
Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection [ Time Frame: cross-sectionnal ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays [ Time Frame: cross-sectionnal ] [ Designated as safety issue: No ]
Same as current
 
 
 
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

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
 
Non-Probability Sample

Adults aged over 18 Under hemodialysis for > 3 months End stage renal failure

Chronic Renal Failure
 
Hemodialysis
Patients under chronic hemodialysis for chronic end stage renal failure
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00695734
JJanssens 4
No
Jean-Paul Janssens, MD, Division of Pulmonary Diseases; Geneva University Hospital
University Hospital, Geneva
Ligue Pulmonaire Genevoise
Principal Investigator: Jean-Paul Janssens, MD Geneva University Hospital
University Hospital, Geneva
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP