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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02782494
Enrollment
200
Registered
2016-05-25
Start date
2016-05-31
Completion date
2018-05-31
Last updated
2016-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients on Dialysis

Keywords

Latent tuberculosis infection, dialysis

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.

Interventions

OTHERExamination of latent TB by QuantiFERON-TB

Examination of latent TB by QuantiFERON-TB both QFT-plus QFT-GIT

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≧ 20 years * Receiving long term dialysis

Exclusion criteria

* Having tuberculosis previously

Design outcomes

Primary

MeasureTime frameDescription
percentage of positive QFT1 weekCompare the results of QFT-plus and QFT-GIT
percentage of positive QFT change1 week and 1 yearCompare the change of the QFT-plus and QFT-GIT report by serial follow up

Secondary

MeasureTime frameDescription
percentage of occurrence of active TB2 yearanticipated 2 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026