Improving the Management of Drug Resistant Tuberculosis in the UK (UK_DR-TB)

December 19, 2017 updated by: University College, London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients with isoniazid resistant tuberculosis disease notified in England to Public Health England's Enhanced Tuberculosis Surveillance System 2009-13 who were not treated at private hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All participants
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

National Institute for Health Research, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/0074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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