Tuberculosis
Conditions
Keywords
tuberculosis, diagnostic test
Brief 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.
Interventions
PROCEDUREblood test, not yet marketed, no trade name
blood test using the new TB diagnostic test
Sponsors
Public Health England
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators.
Exclusion criteria
\- Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years. TB cases: Individuals who are unable to give informed consent. Children aged under 16 years. Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard | 1 year | assess prognostic ability of blood test by assessing development of active TB disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard | 1 year | estimate the sensitivity of new blood tests for detecting TB infection in patients with active TB disease |
| estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj. | 1 year | estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj. |
Countries
United Kingdom
Outcome results
None listed