NCT02875574

Improving the Management of Drug Resistant Tuberculosis in the UK

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 630 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Any treatment regimen	Treatment regimen used to treat patient once isoniazid resistance known (exposure of interest for cohort study)
OTHER	Bacterial mutation	Resistance, compensatory or other mutation in the infecting strain of Mycobacterium tuberculosis (exposure of interest for nested case-control study)

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-08-23
• Last updated: 2017-12-20

Locations

1 site across 1 country: United Kingdom