Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02782494 |
| Other study ID # |
201603066DIPB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
May 11, 2016 |
| Last updated |
December 13, 2016 |
| Start date |
May 2016 |
| Est. completion date |
May 2018 |
Study information
| Verified date |
December 2016 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Ministry of Health and Welfare |
| Study type |
Observational
|
Clinical Trial 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.
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.
