TB PKPD and host transcriptomics
Research type
Research Study
Full title
Predicting tuberculosis treatment outcome using pharmacokinetics, pharmacodynamics and host transcriptomics within a London cohort
IRAS ID
269857
Contact name
Frank L. Kloprogge
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/09/32, UCL Data Protection Registration Number
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Why is this research needed?
Tuberculosis is a top 10 cause of death globally and urgently needs shorter and more effective treatment. However, efficient development of novel and optimisation of existing treatment combinations is currently hindered by the absence of a good biomarker that can predict treatment outcome during the first two months of treatment. Instead patients are followed-up for 12 months after treatment completion which makes trials inefficient and expensive.
We need to better understand how the amount of drug in the patient’s body, the amount of tuberculosis in the patient’s sputum and the patients’ immune response interact with each other. This can form the base for a biomarker that can predict tuberculosis treatment outcome without the need for two years of clinical follow-up.What will be done?
All male and non-pregnant female drug sensitive pulmonary TB patients undergoing standard therapy, aged 18 years or above, will be invited to participate in this observational cohort study. Patients will be ask to give blood to measure the amount of anti-tuberculosis drug and to study the patients’ immune response. Sputum will also be collected to study bacterial load.
The study will be at the Royal Free TB service. The active phase of the study will last for 6 month, generally the time patients are treated for, and patients will subsequently be linked to the national TB database to monitor re-appearance of tuberculosis within the same patient during the 12 months after end of treatment.How will the results be used?
Data arising from this study will be used to inform the design of a biomarker that predicts tuberculosis treatment outcome. When tested and validated in prospective randomised controlled trials this can support scientists and clinicians with treatment shortening and personalisation.REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0007
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion