ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Latent Tuberculosis in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00695734
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Sponsor:
Collaborator:
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva

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

Condition or disease
Chronic 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.

Study Type : Observational
Actual Enrollment : 62 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Hemodialysis
Patients under chronic hemodialysis for chronic end stage renal failure



Primary Outcome Measures :
  1. Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection [ Time Frame: cross-sectionnal ]

Secondary Outcome Measures :
  1. Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays [ Time Frame: cross-sectionnal ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

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