Improving the Management of Drug Resistant Tuberculosis in the UK (UK_DR-TB)

University College London (UCL)

Status: Completed

Conditions: Tuberculosis

Treatments: Drug: Any treatment regimen; Other: Bacterial mutation

Study type: Observational

Funder types: Other

Identifiers

NCT02875574

16/0074

Details and patient eligibility

About

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.

The investigators aim to use data and samples collected from Public Health England and National Health Service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and will have been notified to Public Health England. The study will be conducted at University College London, National Health Service 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.

Enrollment: 630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Isoniazid resistant non-multidrug resistant tuberculosis patients.
• Notified to Public Health England's Enhanced Tuberculosis Surveillance System between 2009-2013.
• Adults aged 18 years and over.
• Patients not treated at private hospitals.

Exclusion criteria

• Non-notified patients.
• Individuals where the site of disease required more than 12 months of treatment.
• Individuals diagnosed post-mortem.

Trial design

630 participants in 1 patient group

All participants

Treatment:

Other: Bacterial mutation

Drug: Any treatment regimen