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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Procedure: blood test, not yet marketed, no trade name

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.

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Hack; Email: v.hack@ucl.ac.uk
• Study Contact Backup: Name: Ibrahim Abubakar, PhD; Email: i.abubakar@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Northwick Park Hospital
  • London, United Kingdom
    • North Middlesex Hospital
  • London, United Kingdom
    • Ealing Hospital
  • London, United Kingdom
    • West Middlesex Hospital NHS Trust
  • London, United Kingdom
    • Barts NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contacts of TB cases; Blood test, not yet marketed, development phase	Procedure: blood test, not yet marketed, no trade name; blood test using the new TB diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Public Health England
• Investigators: Principal Investigator: Ibrahim Abubakar, PhD, University College, London

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: tuberculosis; diagnostic test
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: Next gen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No