- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512484
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments (ACE)
Improving the Detection of Active Tuberculosis in Accident and Emergency (A&E) Departments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, Ha73qx
- Barts NHS Trust
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London, United Kingdom, NW95EQ
- Ealing Hospital
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London, United Kingdom
- West Middlesex Hospital NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- Those with social risk factors who have signs and/or symptoms of TB.
Exclusion Criteria:
- Individuals who are under 16 years
- Individuals who were born in the UK or a low incidence countries and do not have risk factors
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
high risk TB individuals attending A&E Departments
Assessment against inclusion/exclusion criteria in terms of risk of TB.
If eligible, assessment and testing as appropriate for active or latent TB
|
venepuncture, sputum collection, xray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
xray diagnosis of active TB
Time Frame: 1 year
|
clinical signs and symptoms on xray
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
diagnosis of latent TB
Time Frame: 1 year
|
positive blood test result by interferon gamma release assay (IGRA) in line with the manufacturer instructons for the test
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TB A&E study
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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