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

TUBERCULOSIS, PULMONARY Clinical Trial

— ISIT-TB  

Official title:

Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis With the ISIT-TB Prototype in Adults Living in a High Burden Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995406
• Other study ID #: ISIT-TB 001
• Status: Completed
• Start date: January 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: December 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Diagnostic Test:
• ISIT-TB prototype
Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour

Locations

Country	Name	City	State
South Africa	University of Cape Town Lung Institute	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of performance of the diagnostic tool	Determination of the specificity and sensitivity of the diagnostic assay ISIT-TB Prototype for TB in a population living in a high-burden country	Time to bacteriological confirmation 60 days