Detection of Latent Tuberculosis in Hemodialysis Patients
Tracking Information | |||||
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First Received Date ICMJE | June 10, 2008 | ||||
Last Updated Date | June 10, 2008 | ||||
Start Date ICMJE | January 2007 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Detection of Latent Tuberculosis in Hemodialysis Patients | ||||
Official Title ICMJE | Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients | ||||
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 |
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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. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Adults aged over 18 Under hemodialysis for > 3 months End stage renal failure |
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Condition ICMJE | Chronic Renal Failure | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | Hemodialysis
Patients under chronic hemodialysis for chronic end stage renal failure |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 62 | ||||
Completion Date | January 2008 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Switzerland | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00695734 | ||||
Other Study ID Numbers ICMJE | JJanssens 4 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Jean-Paul Janssens, MD, Division of Pulmonary Diseases; Geneva University Hospital | ||||
Study Sponsor ICMJE | University Hospital, Geneva | ||||
Collaborators ICMJE | Ligue Pulmonaire Genevoise | ||||
Investigators ICMJE |
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Information Provided By | University Hospital, Geneva | ||||
Verification Date | June 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |