Detection of Latent Tuberculosis in Hemodialysis Patients

NCT ID: NCT00695734

Last Updated: 2008-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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

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.

Conditions

Chronic Renal Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hemodialysis

Patients under chronic hemodialysis for chronic end stage renal failure

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ligue Pulmonaire Genevoise

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Division of Pulmonary Diseases; Geneva University Hospital

Principal Investigators

Jean-Paul Janssens, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Geneva University Hospital

Geneva, Geneva 14, Switzerland

Countries

Switzerland

Other Identifiers

JJanssens 4

Identifier Type: -

Identifier Source: org_study_id