NCT02512939

Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 675 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.

Detailed description

Currently available blood tests for latent tuberculosis infection (LTBI) identify people who have been previously infected with M. tuberculosis. Whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. These new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown. Mass gatherings, such as the annual Hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. However, the risk of TB infection during the Hajj has not been reliably measured. It is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
PROCEDURE	blood test, not yet marketed, no trade name	blood test using the new TB diagnostic test

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2015-07-31
• Last updated: 2023-05-16

Locations

5 sites across 1 country: United Kingdom