- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211208
Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients (ALISTER)
October 15, 2018 updated by: University of Edinburgh
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.
Study Overview
Status
Unknown
Detailed Description
To improve patient stratification, the investigators have developed a panel of novel circulating liver specific and mechanistic biomarkers that report early acute liver injury.
Such biomarkers are needed as current early biomarkers of liver injury lack sensitivity and specificity.
The panel of biomarkers either have enhanced liver specificity or provide mechanistic insights.
Currently, antituberculosis drug-induced liver injury (ATDILI) is the most frequent side-effect of anti-tuberculosis therapy and this hinders the effective treatment of TB, as it means that treatment regimens are not completed.
At present, the risk of ATDILI means that monitoring of liver function is required, with levels of ALT measured monthly.
If levels of ALT rise to 2-5x the upper limit of normal levels (ULN) and the patient is unwell the frequency of monitoring is increased to biweekly monitoring.
Antibiotic therapy is only changed if levels of ALT remain greater than 3xULN, the patient continues to display symptoms and there is a positive causality assessment that the anti-tuberculosis drugs are causing ATDILI.
This project will recruit patients taking antituberculosis drugs and determine the diagnostic and prognostic value of the biomarker panel, in relation to liver injury as a result of anti-tuberculosis therapy.
Study Type
Observational
Enrollment (Anticipated)
540
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Edinburgh, United Kingdom, EH16 4SA
- Recruiting
- Royal Infirmary Edinburgh
-
Contact:
- Sarah Stedman, Miss
- Phone Number: +44(0) 131 242 6286
- Email: sarah.stedman@ed.ac.uk
-
Contact:
- Adam Hill, Prof
- Email: Adam.Hill318@nhs.net
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Tuberculosis patients being treated at the outpatient clinic at the Royal Infirmary Edinburgh
Description
Inclusion Criteria:
- Patients undergoing treatment for tuberculosis
- Patients with the capacity to give consent
Exclusion Criteria:
- Patients unable to give informed consent
- Patients who refuse to take part
- HIV positive patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tuberculosis drug-induced liver injury
Time Frame: Upto 3 years, or until the end of TB treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2017
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
July 5, 2017
First Posted (Actual)
July 7, 2017
Study Record Updates
Last Update Posted (Actual)
October 16, 2018
Last Update Submitted That Met QC Criteria
October 15, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Infections
- Liver Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Poisoning
- Wounds and Injuries
- Tuberculosis
- Drug-Related Side Effects and Adverse Reactions
- Chemical and Drug Induced Liver Injury
Other Study ID Numbers
- AC16145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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