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

NCT02512939 | Completed

• 1 other identifier: Next gen
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 5

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.

Conditions

Tuberculosis

Keywords

tuberculosis; diagnostic test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard

  1 year

• estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.

  1 year

Study Arms (1)

Contacts of TB cases

EXPERIMENTAL

Blood test, not yet marketed, development phase

Procedure: blood test, not yet marketed, no trade name

Interventions

blood test, not yet marketed, no trade name PROCEDURE

blood test using the new TB diagnostic test

Contacts of TB cases

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University College, London: lead
• Public Health England: collaborator

Study Sites (5)

Barts NHS Trust

London, United Kingdom

Location

Ealing Hospital

London, United Kingdom

Location

North Middlesex Hospital

London, United Kingdom

Location

Northwick Park Hospital

London, United Kingdom

Location

West Middlesex Hospital NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ibrahim Abubakar, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)