Latent TuberculosisACENCT02512484
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
An observational study of Latent Tuberculosis and Active Tuberculosis, run by Public Health England at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis, Active Tuberculosis
- What is being tested?
- venepuncture, sputum collection, xray
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals at high risk of TB
Who may be able to join
- 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.
Who cannot join
- Individuals who are under 16 years
- Individuals who were born in the UK or a low incidence countries and do not have risk factors
Trial locations and contacts
3 sites in 1 country.
Vanessa Hack contact
Ibrahim Abubakar, PhD contact
United Kingdom3 sites
Barts NHS Trust
London, London, Ha73qx
Vanessa Hack, v.hack@ucl.ac.uk
Ealing Hospital
London, London, NW95EQ
Vanessa Hack, v.hack@ucl.ac.uk
West Middlesex Hospital NHS Trust
London, London
Vanessa Hack, v.hack@ucl.ac.uk
About this study
Official title: Improving the Detection of Active Tuberculosis in Accident and Emergency (A&E) Departments
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.
Read the 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.
- Conditions
- Latent Tuberculosis, Active Tuberculosis
- Being tested
- venepuncture, sputum collection, xray
- Keywords
- tuberculosis, accident and emergency
- Medical subject headings
- Latent Tuberculosis, Tuberculosis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venepuncture, sputum collection, xrayProcedure or surgery
venepuncture, sputum collection, xray
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: venepuncture, sputum collection, xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
xray diagnosis of active TB
clinical signs and symptoms on xray
Measured: 1 year
Secondary outcomes (1)
diagnosis of latent TB
positive blood test result by interferon gamma release assay (IGRA) in line with the manufacturer instructons for the test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jo Southern, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512484
- Sponsor's protocol ID
- TB A&E study
- Acronym
- ACE
- Status last verified
- Mar 2016
- First submitted
- 27 Jul 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta RK, Lule SA, Krutikov M, Gosce L, Green N, Southern J, Imran A, Aldridge RW, Kunst H, Lipman M, Lynn W, Burgess H, Rahman A, Menezes D, Rahman A, Tiberi S, White PJ, Abubakar I. Screening for tuberculosis among high-risk groups attending London emergency departments: a prospective observational study. Eur Respir J. 2021 Jun 24;57(6):2003831. doi: 10.1183/13993003.03831-2020. Print 2021 Jun.
PubMed 33737408
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Detection of Active Tuberculosis in Accident and Emergency (A&E) Departments
- ClinicalTrials.gov ID
- NCT02512484
- Acronym / sponsor ID
- ACE / TB A&E study
- Conditions
- Latent Tuberculosis, Active Tuberculosis
- Keywords
- tuberculosis, accident and emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high risk TB individuals attending A&E Departments | – | Procedure: venepuncture, sputum collection, xrayAssessment against inclusion/exclusion criteria in terms of risk of TB. If eligible, assessment and testing as appropriate for active or latent TB |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals at high risk of TB
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who are under 16 years
- Individuals who were born in the UK or a low incidence countries and do not have risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venepuncture, sputum collection, xrayvenepuncture, sputum collection, xray | Procedure or surgery | high risk TB individuals attending A&E Departments |
Primary outcome
xray diagnosis of active TB
Time frame: 1 year
clinical signs and symptoms on xray
1 secondary outcome
diagnosis of latent TB
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 33737408Gupta RK, Lule SA, Krutikov M, Gosce L, Green N, Southern J, Imran A, Aldridge RW, Kunst H, Lipman M, Lynn W, Burgess H, Rahman A, Menezes D, Rahman A, Tiberi S, White PJ, Abubakar I. Screening for tuberculosis among high-risk groups attending London emergency departments: a prospective observational study. Eur Respir J. 2021 Jun 24;57(6):2003831. doi: 10.1183/13993003.03831-2020. Print 2021 Jun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Hack contact
Ibrahim Abubakar, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis and Active Tuberculosis, run by Public Health England at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Hack (v.hack@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
xray diagnosis of active TB (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.