Study name: TB-DILI Status: Recruiting patients
Reintroduction of anti-tuberculosis therapy following drug-induced liver injury: a randomised controlled trial
Contact:
TB-DILI@nottingham.ac.uk
Lead Investigator:
Professor Wei Shen Lim
What is the study about?
In the UK, TB is routinely treated with a combination of four medicines, this is referred to as 4-drug treatment. Most patients can successfully complete their treatment course without any problems. Unfortunately, in some cases, the treatment can begin to cause damage to the liver, this is called drug-induced liver injury (DILI). To protect the liver and encourage it to recover, the TB treatment is stopped.
The aim of the TB-DILI trial is to identify the safest and most effective way to restart treatment for patients that have had their Tuberculosis (TB) treatment stopped due to experiencing drug-induced liver injury (DILI). We will also determine which re-introduction strategy is most cost-effective for the NHS.
Who can take part in the study?
- Aged ≥18 years
- Experienced DILI with standard 4-drug ATT for active pulmonary or extra-pulmonary TB
- Medically suitable for re-introduction of standard 4-drug ATT
What is being tested in the study?
Sequential full-dose reintroduction of a non-Z-containing 3-drug ATT regimen comprising ethambutol, isoniazid and rifiampicin (EHR), as recommended by the American Thoracic Society (ATS) TB guideline.
What is this being compared to?
Sequential full-dose reintroduction of a Z-containing 4-drug ATT regimen comprising ethambutol, isoniazid, rifampicin and pyrazinamide (EHRZ), as recommended by the National Institute for Health and Care Excellence (NICE) TB guideline.
What are we trying to find out?
To determine if reintroduction of a non-pyrazinamide (Z)-containing anti-tuberculosis therapy (ATT) regimen results in a lower drug-induced liver injury (DILI) recurrence rate compared to a Z-containing ATT regimen in adults who have experienced an episode of DILI when being treated for active tuberculosis (TB)
How many patients do we need?
350 patients recruited across approximately 40 sites
Funder:
NIHR HTA
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