Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis (ISIT-TB)

bioMérieux

Status: Completed

Conditions: TUBERCULOSIS, PULMONARY

Treatments: Diagnostic Test: ISIT-TB prototype

Study type: Observational

Funder types: Industry

Identifiers

NCT04995406

ISIT-TB 001

Details and patient eligibility

About

ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.

Full description

This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.

Enrollment: 722 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
• Willingness to give consent to take part in the study.
• Aged >18 years old.
• Healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary TB patients.

Exclusion criteria

• Pregnant woman
• A person who has received treatment for active TB or LTBI in the past 24 months

Trial design

722 participants in 4 patient groups

Active TB ATB

Description:

Participants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity

Treatment:

Diagnostic Test: ISIT-TB prototype

Latent Tuberculosis Infections LTBI

Description:

Participants with presumed latent TB infection

Treatment:

Diagnostic Test: ISIT-TB prototype

Healthy controls HC

Description:

Participants who do not have Active or Latent tuberculosis or other pathologies investigated in this study

Treatment:

Diagnostic Test: ISIT-TB prototype

Non-tuberculous symptomatic participants

Description:

This cohort refers to participants who are known with chronic respiratory conditions and present with one or more signs and symptoms suggestive of TB, but in whom microbiological testing is negative.

Treatment:

Diagnostic Test: ISIT-TB prototype