Improving the Management of Drug Resistant Tuberculosis in the UK

Completed

• Conditions: Tuberculosis
• Interventions: Drug: Any treatment regimen; Other: Bacterial mutation

• Registration Number: NCT02875574
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-23
• Study Start: 2016-11
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Any treatment regimen	-
All participants	Bacterial mutation	-

Primary Outcome Measures

Name	Time	Method
Treatment outcome	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.

Trial Locations

Locations (1)

Royal Free London NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom