Improving the Management of Drug Resistant Tuberculosis in the UK

Tuberculosis Clinical Trial

— UK_DR-TB  

Official title:

Improving the Management of Drug Resistant Tuberculosis in the UK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875574
• Other study ID #: 16/0074
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: December 19, 2017
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS Foundation Trust	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Study webpage