TB ShORRT UK: an observational study of new, shorter treatment regimens for drug-resistant tuberculosis in the UK

ISRCTN	ISRCTN14005421
DOI	https://doi.org/10.1186/ISRCTN14005421
IRAS number	317172
Secondary identifying numbers	IRAS 317172

Submission date: 20/12/2022
Registration date: 01/08/2023
Last edited: 31/07/2023

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Until 2022 most people treated for drug-resistant TB in the world received treatment courses of 12-18 months with at least 5 toxic drugs including daily intra-muscular injections with a drug that carried a high risk of causing hearing loss.
Fortunately medical researchers have recently discovered new highly effective drug regimens which are shorter (6 months) and use therapies with fewer side effects (no deafness) not requiring injections.
TB ShORRT UK is designed to determine whether these new treatment regimens for drug-resistant TB will perform as well in the UK context, by recording and following closely the experiences of TB patients treated with them in the UK. The study protocol is derived from a World Health Organisation template and there are similar studies underway in more than a dozen other countries.

Who can participate?
Any patient of any age receiving TB treatment that is not the standard 'first-line' regimen will be eligible to take part - most participants will be people with drug-resistant TB but people unable to tolerate 'first-line' treatments will also be invited to join.

What does the study involve?
No additional tests or interventions will be required for the study. Data will be collected from the usual clinical visit schedule.

What are the possible benefits and risks of participating?
There are no risks to participation - treatment will be unchanged and there are no additional clinic visits or tests to those that would ordinarily be the 'standard of care' expected - the data (blood test results, weight, symptoms) will be recorded and analysed together with those of other patients.

Where is the study run from?
University College London Hospitals NHS Foundation Trust

When is the study starting and how long is it expected to run for?
February 2022 to February 2028

Who is funding the study?
The study team are applying for funding from NIHR (Research for Patient Benefit scheme)

Who is the main contact?
Prof Dave Moore, davidajmoore1@nhs.net

Contact information

Prof Dave Moore
Principal Investigator

Hospital for Tropical Diseases
2nd Floor, Maple House
University College London Hospitals NHS Trust
London
W1T 7NF
United Kingdom

ORCID ID	0000-0002-3748-0154
Phone	+44 20 3456 7890
Email	davidajmoore1@nhs.net

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	TB ShORRT UK: an implementation evaluation of shorter, all-oral regimens for drug-resistant tuberculosis in the United Kingdom
Study acronym	TB ShORRT UK
Study objectives	Novel, shorter regimens for treatment of MDRTB have been recommended by the WHO. In clinical trials these have been shown to be better tolerated and more efficacious than existing drug regimens. To accelerate adoption in countries, local demonstration of comparative performance, tolerability and acceptability to patients and healthcare staff is critical. This implementation research project, closely mirroring the parent template protocol developed by WHO/TDR, will gather the evidence required to determine if such regimens are well suited to the UK context and inform future policy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Tuberculosis resistant to first-line drug therapies or tuberculosis in patients intolerant of first-line drug therapies
Intervention	UK TB patients with drug-resistant TB or intolerant of first-line TB medications will receive regimens composed of second-line therapies as part of their standard of care. All such patients will be invited to participate in an observational cohort study to advance our understanding of the safety, tolerability and efficacy of new, shorter, all-oral treatment regimens which are being introduced worldwide, and presently in the UK. No additional tests or interventions will be required for the study. Standardised collection of data from usual clinical visit schedule will facilitate aggregate analyses.
Intervention type	Mixed
Primary outcome measure	1. Effectiveness, defined as the proportion of patients with a favourable outcome of "cured" or "treatment completed without clinical or bacteriologic evidence of failure" up to 12 months after the end of treatment 2. Safety, assessed as the proportion of patients experiencing a serious adverse event during treatment and up to 6 months after the end of treatment
Secondary outcome measures	1. Health-related quality of life, assessed using the EQ-5D-5L and FACIT-TB questionnaires at baseline, 4 months, end of treatment and 12 months after treatment completion 2. Stigma, assessed using the Modified Cataldo Lung Cancer Scale at baseline, 4 months, end of treatment and 12 months after treatment completion 3. Acceptability to healthcare workers, assessed using semi-structured interviews and framework analysis with two rounds of interviews 12-18 months apart 4. Cost-effectiveness of shorter all-oral regimens compared to longer course regimens, utilising a Markov model to assess the incremental cost incurred per QALY gained
Overall study start date	01/02/2022
Completion date	28/02/2028

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	800
Key inclusion criteria	UK TB patients receiving a treatment regimen other than first-line treatment
Key exclusion criteria	1. Patients unable or unwilling to provide informed consent
Date of first enrolment	01/11/2023
Date of final enrolment	28/02/2027

Locations

Countries of recruitment

England
Northern Ireland
Scotland
United Kingdom
Wales

Study participating centre

University College London Hospitals NHS Foundation Trust

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust
Hospital/treatment centre

235 Euston Rd
London
NW1 2BU
England
United Kingdom

Phone	+44 20 3456 7890
Email	uclh.randd@nhs.net
Website	https://www.uclh.nhs.uk/Pages/home.aspx
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Other

Investigator initiated and funded at present - funding application in process

No information available

Results and Publications

Intention to publish date	31/03/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. Planned dissemination of results to all participants and PPI group in separate workshops.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at later date

Editorial Notes

28/07/2023: Study's existence confirmed by the NIHR.