Skip to main content
Clinical Trials/NCT02782494
NCT02782494UnknownNot Applicable

Comparing Consistency of QuantiFERON-TB Gold Plus and QuantiFERON-TB Gold for Latent Tuberculosis in Dialysis Population

National Taiwan University Hospital1 site in 1 country200 target enrollmentStarted: May 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
percentage of positive QFT

Study Overview

Brief Summary

In patients receiving long term dialysis, using new generation of QuantiFERON-TB Gold Plus can have less result variability in inter-experiment and serial follow up in comparing with QuantiFERON-TB Gold In-tube.

Detailed Description

Tuberculosis (TB) remains one of the most important infectious diseases worldwide. According to the World Health Organization (WHO) estimates, there were 9 million new TB cases and 1.5 million related deaths in 2013. Future control strategies include early treatment for preventing transmission and treatment of latent TB infection (LTBI) for reducing reactivation. Patients with renal failure undergoing dialysis have increased risk of TB due to attenuated cellular immunity. For instance, their risk of developing active TB in the dialysis population is 7.8-25 times higher than that of the general population. However, TB diagnosis is usually delayed because of frequent extra-pulmonary manifestations. Thus, LTBI detection in this specific group is important.

Positive results of interferon-gamma release assays (IGRAs) and the exclusion of active TB are the current diagnostic bases of LTBI, which is a precursor of tuberculosis reactivation. However, recent reports show a high negative reversion rate of quantiFERON Gold In-tube (QFT-GIT), a kind of IGRA, in cohorts of health care workers (33% after 18 weeks) close TB contacts (35% after six months), and patients receiving long-term dialysis (46% after six months). This phenomenon questions the clinical significance of a single positive IGRA result. Increasing the IGRA threshold or doing serial follow-up to improve specificity have both been suggested but there is no comparison by the risk of TB development.

Therefore, increasing the accuracy and stability and then improving the rate of negative conversion from positive IGRA results are very important. Currently, new generation of QuantiFERON-TB Gold Plus includes two tubes for CD4 and CD8 T cells response, which can indicate TB immune response more specifically. The investigators applied this project to compare the performance of diagnosing LTBI by QuantiFERON-TB Gold Plus in comparing QuantiFERON-TB Gold In-tube.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≧ 20 years
  • Receiving long term dialysis

Exclusion Criteria

  • Having tuberculosis previously

Outcomes

Primary Outcomes

percentage of positive QFT

Time Frame: 1 week

Compare the results of QFT-plus and QFT-GIT

percentage of positive QFT change

Time Frame: 1 week and 1 year

Compare the change of the QFT-plus and QFT-GIT report by serial follow up

Secondary Outcomes

  • percentage of occurrence of active TB(2 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials