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
  Purpose

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


Condition
Chronic Renal Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis
Patients under chronic hemodialysis for chronic end stage renal failure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695734

Locations
Switzerland
Geneva University Hospital
Geneva, Geneva 14, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Ligue Pulmonaire Genevoise
Investigators
Principal Investigator: Jean-Paul Janssens, MD Geneva University Hospital
  More Information

No publications provided

Responsible Party: Jean-Paul Janssens, MD, Division of Pulmonary Diseases; Geneva University Hospital
ClinicalTrials.gov Identifier: NCT00695734     History of Changes
Other Study ID Numbers: JJanssens 4
Study First Received: June 10, 2008
Last Updated: June 10, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
hemodialysis
end stage renal failure
tuberculosis
latent tuberculosis infection
Patients under hemodialysis for end stage renal failure

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Tuberculosis
Latent Tuberculosis
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 21, 2014