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NCT01685086 Clinical Trial

Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis

To Determine the Prevalence of Latent Tuberculosis in Each Group Clinical Trial

Official title:
Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01685086
Other study ID # 201110013RC
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2012
Last updated September 12, 2012
Start date March 2012

Study information
Verified date November 2011
Source National Taiwan University Hospital
Contact Chin-Chung Shu, MD
Phone 886972653087
Email ccshu139@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

To follow-up the latent tuberculosis infection and evaluate the risk of developing active tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis

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 and severe chronic kidney disease. 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 follow-up for the primary outcome of active TB occurrence.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- older than 20 years old

- Estimated CCr < 30 ml/min as group of severe chronic kidney disease

- Long-term (>3months) dialysis as dialysis group

Exclusion Criteria:

- refusal of recruitment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of active tuberculosis 2 years No
Secondary Latent tuberculosis infection 2 years No