Detection of Latent Tuberculosis in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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

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Chronic Renal Failure

Keywords

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hemodialysis end stage renal failure tuberculosis latent tuberculosis infection Patients under hemodialysis for end stage renal failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hemodialysis

Patients under chronic hemodialysis for chronic end stage renal failure

No interventions assigned to this group

Eligibility Criteria

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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

Responsible Party

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Division of Pulmonary Diseases; Geneva University Hospital

Principal Investigators

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Jean-Paul Janssens, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospital

Geneva, Geneva 14, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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JJanssens 4

Identifier Type: -

Identifier Source: org_study_id