Improving the Management of Drug Resistant Tuberculosis in the UK

NCT02875574 | Completed

• 1 other identifier: 16/0074
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Isoniazid; Drug Resistance

Outcome Measures

Primary Outcomes (1)

• Treatment outcome

  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

Study Arms (1)

All participants

Drug: Any treatment regimen; Other: Bacterial mutation

Interventions

Any treatment regimen DRUG

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

All participants

Bacterial mutation OTHER

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

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Non-notified patients.
• Individuals where the site of disease required more than 12 months of treatment.
• Individuals diagnosed post-mortem.

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Free London NHS Foundation Trust

London, Greater London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 23, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

GB (1)