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Improving the Management of Drug Resistant Tuberculosis in the UK

NCT ID: NCT02875574

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Tuberculosis

Keywords

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Isoniazid Drug Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All participants

Any treatment regimen

Intervention Type DRUG

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

Bacterial mutation

Intervention Type OTHER

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

Interventions

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Any treatment regimen

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

Intervention Type DRUG

Bacterial mutation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Free London NHS Foundation Trust

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16/0074

Identifier Type: -

Identifier Source: org_study_id