Improving the Detection of Active Tuberculosis in Acciden... | NCT02512484

Studies
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments

NCT02512484

Sponsor

Public Health England

Status

Unknown status

Last Update Posted

Mar 16, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Latent Tuberculosis
Active Tuberculosis

Interventions

venepuncture, sputum collection, xray

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jul 27, 2015

First Submission Date that Met QC Criteria

Jul 30, 2015

First Posted Date

Jul 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jo Southern, Clinical Research Lead, Public Health EnglandPrincipal Investigator

Lead Sponsor

Public Health EnglandOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: venepuncture, sputum collection, xray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
venepuncture, sputum collection, xray	Procedure	venepuncture, sputum collection, xray	high risk TB individuals attending A&E Departments

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
xray diagnosis of active TB	clinical signs and symptoms on xray	1 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals at high risk of TB

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanessa Hack	Contact			v.hack@ucl.ac.uk
Ibrahim Abubakar, PhD	Contact			i.abubakar@ucl.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barts NHS Trust		London	London	Ha73qx	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33737408	Derived	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.

ID	Term
D055985	Latent Tuberculosis
D014376	Tuberculosis
D004630	Emergencies

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

ID	Term
D001800	Blood Specimen Collection
D014965	X-Rays

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis