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OpenTrials
Completed

NCT Number: NCT02875574

Improving the Management of Drug Resistant Tuberculosis in the UK

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Free London NHS Foundation Trust

London, Greater London, NW3 2QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Any treatment regimen

Drug

Treatment regimen used to treat patient once isoniazid resistance known (exposure of interest for cohort study)

Bacterial mutation

Other

Resistance, compensatory or other mutation in the infecting strain of Mycobacterium tuberculosis (exposure of interest for nested case-control study)

Primary outcomes

  1. Treatment outcome

    Time frame: Up to 12 months after the start of treatment

    Negative versus positive treatment outcomes attributable to the treatment regimen commenced once isoniazid resistance known. Taken from clinical records.

    Also used to define cases and controls for nested case-control study.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Acronym: UK_DR-TB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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