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

Completed

• Conditions: TUBERCULOSIS, PULMONARY

• 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

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