Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection (PREDICT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01162265|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : October 1, 2020
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.
|Condition or disease|
|Tuberculosis Latent Tuberculosis|
|Study Type :||Observational|
|Actual Enrollment :||10000 participants|
|Official Title:||Prognostic Value of Interferon Gamma Release Assays in Predicting Active Tuberculosis Among Individuals With, or at Risk of, Latent Tuberculosis Infection|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 30, 2015|
|Actual Study Completion Date :||June 30, 2016|
Contacts of active cases of tuberculosis
new entrants from high incidence (>40/100000) countries.
- Development of active TB. Prognostic values of tests quantified as incidence rate ratios (RR) among contacts and new entrants [ Time Frame: two years ]
- Side effects from chemoprophylaxis [ Time Frame: two years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162265
|Southall, London, United Kingdom, UB1 3HW|
|St George's Hospital|
|Tooting, London, United Kingdom, SW17 0QT|
|London, United Kingdom, E9 6SR|
|Principal Investigator:||Ajit Lalvani, MD, PhD||Imperial College London|