Latent tuberculosis infection (LTBI) Infections and Infestations Tuberculosis
Conditions
Interventions
Current interventions as of 30/07/2024:
Participants will be randomised 2:1 into either the intervention arm (C-Tb skin test) or control arm (standard of care IGRA blood test)
Method of randomisatio
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/07/2024: 1. Aged 16 – 65 years 2. Eligible for LTBI testing with IGRA and treatment for LTBI according to UK guidance 3. Willing and able to provide written informed consent 4. Willing and able to comply with the trial _____ Previous inclusion criteria: 1. Aged 16 – 65 years 2. Eligible for LTBI testing with IGRA and treatment for LTBI according to UK guidance 3. Willing and able to provide written informed consent 4. Willing and able to comply with the trial, including the randomised test(s) and adherence to follow up visits
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/07/2024: 1. Displaying any symptoms or signs of active TB disease _____ Previous exclusion criteria: 1. Allergy to C-Tb product or any of its constituents 2. Displaying any symptoms or signs of active TB disease 2.1. Unexplained fever 2.2. Cough (more than 3 weeks) 2.3. Haemoptysis 2.4. Blood in sputum 2.5. Unexplained weight loss 2.6. Drenching night sweats 2.7. Lymph node swelling 3. Women who are breastfeeding, pregnant or plan to become pregnant during the study 4. Women of childbearing potential not using contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 30/07/2024: Initiation of LTBI treatment within 12 weeks (following a positive result), as determined by confirmation of LTBI treatment medications issued by pharmacy. _____ Previous primary outcome measure: Initiation of LTBI treatment (within a defined 24 ± 4 week follow-up period) based on a positive result of the randomised test. The treatment initiation is based on pharmacy records that confirm the issuance of medications for LTBI treatment within a defined 24±4 week follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/07/2024: 1. Related to patient and process outcomes (impact) on the LTBI pathway process outcomes: • Acceptance of C-Tb testing • Failure to have C-Tb test read within 2-3 days among participants receiving C-Tb test • Positive test result among participants receiving the randomised test • Initiating treatment among participants receiving C-Tb test • Initiating treatment among participants testing C-Tb positive • Acceptance of LTBI treatment among participants, determined by verbal agreements. • Losses to follow up (default rate) between diagnosis with LTBI and starting treatment • Time from testing to starting preventative therapy 2. Safety • Local reactions • Systemic reactions i. Serious adverse events at least possibly related to the diagnostic test received ii.Pre-defined adverse events _____ Previous secondary outcome measures: 1. Safety: 1.1. Local and systemic reactions in participants randomised to the C-Tb test assessed by clinicians using a standard checklist at follow-up visits 2. Process outcomes related to impact on the LTBI pathway: 2.1. For participants randomised to C-Tb, failure to return for C Tb reading within 2-3 days as recommended by the manufacturer will be documented on the CRF at the scheduled follow-up visit for reading C-Tb results 2.2. Acceptance of LTBI treatment among participants with a positive result of the randomised test, as determined by verbal agreement, will be recorded on the CRF at each follow-up visit 2.3. Initiation of LTBI treatment among those with a positive result of the randomised test will be assessed based on confirmation of LTBI treatment medications issued by the pharmacy within a defined 24±4 week follow-up period 2.4. Losses to follow-up between diagnosis with LTBI and starting LTBI treatment. Participants will be deemed lost to follow-up if they fail to attend any of the scheduled visits/appointments and are still not contactable at the end of the diagnostic fo | — |
Countries
England, United Kingdom
Contacts
Public ContactEllen Owen-Powell
Outcome results
None listed