ALISTER
Research type
Research Study
Full title
Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients.
IRAS ID
217487
Contact name
James Dear
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
A panel of highly sensitive circulating biomarkers for acute liver injury have been identified and demonstrated to identify liver injury on first presentation to hospital before standard tests are elevated in patients with paracetamol overdose. Furthermore, some of this panel can identify which patients will develop clinically important liver failure once liver injury has started.
We wish to test these biomarkers in patients with active and latent tuberculosis to see if they can be used to stratify patients undertaking anti-tuberculosis drug therapy. Anti-tuberculosis drug induced liver injury is the most frequent side-effect of anti-tuberculosis therapy, affecting 2-5% of tuberculosis patients seen at the Royal Infirmary Edinburgh and hindering their effective treatment. The biomarkers we will use in this study have the potential to be translated into use in a point of care assay, so as to rapidly benefit patients.
Patients will be recruited from the TB out-patient clinic at the Royal Infirmary Edinburgh. Blood samples will be taken every time the patient visits the clinic and also retrieved from the biochemistry lab. The biomarkers in the blood samples will be analysed to determine if they rise in patients who develop liver injury.
This clinical study is being funded by the Medical Research Council (MRC) and University of Edinburgh as part of a doctoral training grant.
REC name
West of Scotland REC 5
REC reference
17/WS/0017
Date of REC Opinion
22 Mar 2017
REC opinion
Further Information Favourable Opinion