UK DR-TB management v1
Research type
Research Study
Full title
Improving the management of drug resistant tuberculosis in the UK.
IRAS ID
172394
Contact name
Helen Stagg
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/04/28, University College London data protection
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
The 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible.
Currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. Data from randomised controlled trials, the peak quality of evidence, is sparse. It is thus important that studies using pre-existing observational data are undertaken.
We aim to use data and samples collected from Public Health England and NHS hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease and b) how different causes of drug resistance in the infecting bacteria influence a). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and their disease notified to Public Health England. The study will be conducted at University College London, NHS hospitals and Public Health England and will last until December 2017. Patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
16/LO/1269
Date of REC Opinion
29 Jul 2016
REC opinion
Favourable Opinion