Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection (PREDICT)
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at increased risk of TB. Those at increased risk are defined as either newly arrived immigrants or people who have been in contact with TB cases. The study will also provide information on the cost effectiveness of different testing strategies, such as the two step testing approach recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment programme.
10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in London. All participants will have the skin test and blood taken for both assays. Disease status of participants will then be followed up for an average of 24 months using the national register of clinical reports, a phone call and the national microbiological database. The risk of developing active disease is highest in the first two years after exposure. During followup there will be no additional diagnostic procedures unless symptoms occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random 25% of participants, will have a repeat IGRA test shortly after the first test to investigate whether the skin test affects the result of the blood test.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection|
- Development of active TB. Prognostic values of tests quantified as incidence rate ratios (RR) among contacts and new entrants [ Time Frame: two years ] [ Designated as safety issue: No ]
- Side effects from chemoprophylaxis [ Time Frame: two years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
A biobank will be established from samples collected in this study, subject to routine HTA requirements in the UK. This has full ethical approval and is included in the consent to take part in the study.
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Contacts of active cases of tuberculosis
new entrants from high incidence (>40/100000) countries.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162265
|Southall, London, United Kingdom, UB1 3HW|
|St George's Hospital|
|Tooting, London, United Kingdom, SW17 0QT|
|London, United Kingdom, E9 6SR|
|Principal Investigator:||Frances Drobniewski, MD, PhD||Health Protection Agency, United Kingdom|
|Principal Investigator:||Ajit Lalvani, MD, PhD||Imperial College London|