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Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term Dialysis

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. Identifier: NCT01311999
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis

Condition or disease
To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy

Detailed Description:

Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population. To control TB, we should prevent further TB transmission via early diagnosis and treatment of latent TB. In screening the risk population for TB, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of United States Renal Data System) than other countries in the world. In particular, the dialysis patients usually has an extrapulmonary presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in those dialysis patients for monitor them from active tuberculosis.

Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent TB and have been proven useful for those being immunocompromised, and having BCG vaccination. For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin test. However, previous studied rarely observed the patients receiving peritoneal dialysis. Besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis by using IGRAs. We also kept one-year follow-up for the primary outcome of active TB occurrence.

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Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term Dialysis
Study Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

IGRA-positive group
The subjects who have positive results of interferon-gamma release assay
IGRA-negative group
The subjects who have negative results of interferon-gamma release assay

Primary Outcome Measures :
  1. Development of active tuberculosis [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients receiving long-term dialysis

Inclusion Criteria:

  • age equal to or more than 18-years old
  • having received dialysis more than 3 months

Exclusion Criteria:

  • Positive HIV test
  • Liver cirrhosis, Child-Pugh class C
  • Receiving long-term systemic corticosteroid use
  • Receiving chemotherapy within recent three months
  • Life span is less than one year
  • Being suspected to have active tuberculosis

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 identifier (NCT number): NCT01311999

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National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital Identifier: NCT01311999    
Other Study ID Numbers: 201009057R
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013
Keywords provided by National Taiwan University Hospital:
latent tuberculosis, renal failure, dialysis, interferon-gamma release assay
Additional relevant MeSH terms:
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Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections