Tuberculosis resistant to first-line drug therapies or tuberculosis in patients intolerant of first-line drug therapies Respiratory
Conditions
Interventions
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 in
Sponsors
University College London Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: UK TB patients receiving a treatment regimen other than first-line treatment
Exclusion criteria
Exclusion criteria: 1. Patients unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed