NCT02512484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

July 27, 2015

Last Update Submit

March 15, 2016

Conditions

Keywords

tuberculosisaccident and emergency

Outcome Measures

Primary Outcomes (1)

  • xray diagnosis of active TB

    clinical signs and symptoms on xray

    1 year

Secondary Outcomes (1)

  • diagnosis of latent TB

    1 year

Study Arms (1)

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

venepuncture, sputum collection, xray

high risk TB individuals attending A&E Departments

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals at high risk of TB

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals who are under 16 years
  • Individuals who were born in the UK or a low incidence countries and do not have risk factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Barts NHS Trust

London, London, Ha73qx, United Kingdom

Location

Ealing Hospital

London, London, NW95EQ, United Kingdom

Location

West Middlesex Hospital NHS Trust

London, London, United Kingdom

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Retention of residual blood samples after inital testing, with appropriate consent to do so from individuals and ethics committee.

MeSH Terms

Conditions

Latent TuberculosisTuberculosisEmergencies

Interventions

Blood Specimen CollectionX-Rays

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Vanessa Hack

CONTACT

Ibrahim Abubakar, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Lead

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 31, 2015

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations