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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02512484
Other study ID # TB A&E study
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 27, 2015
Last updated March 15, 2016
Start date May 2016
Est. completion date December 2017

Study information

Verified date March 2016
Source Public Health England
Contact Vanessa Hack
Email v.hack@ucl.ac.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A&E) Departments of hospitals. This is often the case for those in hard to reach groups, who are also those often at highest risk of TB. This study seeks to assess whether A&E Departments are effective sites for the identification and onward management of TB, both in its latent and active forms.


Description:

This proposal is focused upon early diagnosis, referral and treatment of active tuberculosis, which has two key components: 1) ensuring optimal outcome for individuals; 2) contributing to disease control in public health terms by preventing further spread.

A&E Departments are an important point of testing and referral for the client group that constitute those at greatest risk, as for many this will be their only interaction with the health service. Currently, A&E Departments contribute about 20% of those diagnosed with TB. The majority of these individuals are most likely to have presented with symptoms indicative of disease, compared to those attending for other reasons who would have been unlikely to have been tested or referred.

This study will seek to evaluate specific measures currently being undertaken by Public Health England and the NHS to control TB as well as investigate whether case finding for active TB in A&E departments would improve TB control. The economic impact of these interventions will be evaluated, providing a measure of its value for money.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

1. Individuals 16 years or older, who are new entrants from high incidence countries who have arrived in the UK within the past 2 years or those born in high incidence countries who entered the UK more than five years ago, but have spent more than one year (cumulative) in the past five years in a high incidence country.

2. Those with social risk factors who have signs and/or symptoms of TB.

Exclusion Criteria:

1. Individuals who are under 16 years

2. Individuals who were born in the UK or a low incidence countries and do not have risk factors

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
venepuncture, sputum collection, xray
venepuncture, sputum collection, xray

Locations

Country Name City State
United Kingdom Barts NHS Trust London
United Kingdom Ealing Hospital London
United Kingdom West Middlesex Hospital NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary xray diagnosis of active TB clinical signs and symptoms on xray 1 year No
Secondary diagnosis of latent TB positive blood test result by interferon gamma release assay (IGRA) in line with the manufacturer instructons for the test 1 year No
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