Improving the Detection of Active Tuberculosis in Accident and Emergency Departments

Latent Tuberculosis Clinical Trial

— ACE  

Official title:

Improving the Detection of Active Tuberculosis in Accident and Emergency (A&E) Departments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02512484
• Other study ID #: TB A&E study
• 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

Related Conditions & MeSH terms

• Active Tuberculosis
• Emergencies
• Latent Tuberculosis
• Tuberculosis

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