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Clinical Trials/NCT02875574
NCT02875574
Completed
Not Applicable

Improving the Management of Drug Resistant Tuberculosis in the UK

University College, London1 site in 1 country630 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Any treatment regimen
Conditions
Tuberculosis
Sponsor
University College, London
Enrollment
630
Locations
1
Primary Endpoint
Treatment outcome
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Isoniazid resistant non-multidrug resistant tuberculosis patients.
  • Notified to Public Health England's Enhanced Tuberculosis Surveillance System between 2009-
  • 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.

Arms & Interventions

All participants

Intervention: Any treatment regimen

All participants

Intervention: Bacterial mutation

Outcomes

Primary Outcomes

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.

Study Sites (1)

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