Detection of Latent Tuberculosis in Hemodialysis Patients - Full Text View

Sponsor:	University Hospital, Geneva
Collaborator:	Ligue Pulmonaire Genevoise
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00695734

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:	Case-Only, 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:

MedlinePlus related topics: Dialysis Kidney Failure Tuberculosis

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Locations

Switzerland, Geneva 14
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:	Division of Pulmonary Diseases; Geneva University Hospital ( Jean-Paul Janssens, MD )
Study ID Numbers:	JJanssens 4
Study First Received:	June 10, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00695734 History of Changes
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:

Bacterial Infections
Gram-Positive Bacterial Infections
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Mycobacterium Infections
Tuberculosis
Kidney Diseases
Actinomycetales Infections
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010