Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients

NCT03211208 | Completed

• 1 other identifier: AC16145
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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. The investigators 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. 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.

Conditions

Drug-Induced Liver Injury; Anti-Tuberculous Drug Reaction; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Anti-tuberculosis drug-induced liver injury

  Anti-tuberculosis drug-induced liver injury defined as ALT elevation more than three times the ULN in the presence of hepatitis symptoms and/or jaundice, or five times the ULN in the absence of symptoms. This is a 'proof of concept' study to determine whether a panel of biomarkers are elevated in tuberculosis patients who develop anti-tuberculosis drug-induced liver injury.

  Upto 3 years, or until the end of TB treatment

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Tuberculosis patients being treated at the outpatient clinic at the Royal Infirmary Edinburgh

You may qualify if:

• Patients undergoing treatment for tuberculosis
• Patients with the capacity to give consent

You may not qualify if:

• Patients unable to give informed consent
• Patients who refuse to take part
• HIV positive patients

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Rupprechter SAE, Sloan DJ, Oosthuyzen W, Bachmann TT, Hill AT, Dhaliwal K, Templeton K, Matovu J, Sekaggya-Wiltshire C, Dear JW. MicroRNA-122 and cytokeratin-18 have potential as a biomarkers of drug-induced liver injury in European and African patients on treatment for mycobacterial infection. Br J Clin Pharmacol. 2021 Aug;87(8):3206-3217. doi: 10.1111/bcp.14736. Epub 2021 Jan 26.

  PMID: 33432705 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and whole blood samples

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury; Tuberculosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: July 7, 2017
• Study Start: May 22, 2017
• Primary Completion: March 22, 2020
• Study Completion: March 22, 2020
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)