Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis

Completed

• Conditions: TUBERCULOSIS, PULMONARY
• Interventions: Diagnostic Test: ISIT-TB prototype

• Registration Number: NCT04995406
• Lead Sponsor: BioMérieux

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-09
• Study Start: 2022-01-03
• Primary Completion: 2023-05-01
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active TB ATB	ISIT-TB prototype	Participants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity
Latent Tuberculosis Infections LTBI	ISIT-TB prototype	Participants with presumed latent TB infection
Healthy controls HC	ISIT-TB prototype	Participants who do not have Active or Latent tuberculosis or other pathologies investigated in this study
Non-tuberculous symptomatic participants	ISIT-TB prototype	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of performance of the diagnostic tool	Time to bacteriological confirmation 60 days	Determination of the specificity and sensitivity of the diagnostic assay ISIT-TB Prototype for TB in a population living in a high-burden country

Trial Locations

Locations (1)

University of Cape Town Lung Institute; 🇿🇦 Cape Town, South Africa