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.|
|ClinicalTrials.gov Identifier: NCT01311999|
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : December 4, 2013
|Condition or disease|
|To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy|
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.
|Study Type :||Observational|
|Actual Enrollment :||234 participants|
|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|
The subjects who have positive results of interferon-gamma release assay
The subjects who have negative results of interferon-gamma release assay
- Development of active tuberculosis [ Time Frame: 3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT01311999
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chin-Chung Shu, MD||National Taiwan University Hospital|