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Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection (NextGen)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
blood test, not yet marketed, no trade name
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring tuberculosis, diagnostic test

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators.

Exclusion Criteria:

- Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years.

TB cases: Individuals who are unable to give informed consent. Children aged under 16 years.

Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.

Sites / Locations

  • Barts NHS Trust
  • Ealing Hospital
  • North Middlesex Hospital
  • Northwick Park Hospital
  • West Middlesex Hospital NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contacts of TB cases

Arm Description

Blood test, not yet marketed, development phase

Outcomes

Primary Outcome Measures

assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard
assess prognostic ability of blood test by assessing development of active TB disease.

Secondary Outcome Measures

assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard
estimate the sensitivity of new blood tests for detecting TB infection in patients with active TB disease
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.

Full Information

First Posted
July 28, 2015
Last Updated
May 12, 2023
Sponsor
University College, London
Collaborators
Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT02512939
Brief Title
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
Acronym
NextGen
Official Title
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Public Health England

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.
Detailed Description
Currently available blood tests for latent tuberculosis infection (LTBI) identify people who have been previously infected with M. tuberculosis. Whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. These new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown. Mass gatherings, such as the annual Hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. However, the risk of TB infection during the Hajj has not been reliably measured. It is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, diagnostic test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contacts of TB cases
Arm Type
Experimental
Arm Description
Blood test, not yet marketed, development phase
Intervention Type
Procedure
Intervention Name(s)
blood test, not yet marketed, no trade name
Intervention Description
blood test using the new TB diagnostic test
Primary Outcome Measure Information:
Title
assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard
Description
assess prognostic ability of blood test by assessing development of active TB disease.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard
Description
estimate the sensitivity of new blood tests for detecting TB infection in patients with active TB disease
Time Frame
1 year
Title
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
Description
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators. Exclusion Criteria: - Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years. TB cases: Individuals who are unable to give informed consent. Children aged under 16 years. Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Abubakar, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts NHS Trust
City
London
Country
United Kingdom
Facility Name
Ealing Hospital
City
London
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
London
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
London
Country
United Kingdom
Facility Name
West Middlesex Hospital NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection

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