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

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

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

Study Overview

• Status: Completed
• Conditions: TUBERCULOSIS, PULMONARY
• Intervention / Treatment: Diagnostic test: ISIT-TB prototype

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 Type: Observational
• Enrollment (Actual): 722

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7700
    • University of Cape Town Lung Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Active TB cases will be prospectively recruited from the primary care TB clinics and participating hospitals. Healthy adults will be recruited using the healthy participant database of the participating hospitals. For LTBI population, individuals presenting to primary care facilities for reasons other than suspected TB will be approached and invited to participate as possible LTBI should they be assessed as being at increased risk for TB infection as described in the inclusion/exclusion criteria. Non-infectious respiratory disease controls will be recruited from the participing hospitals.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BioMérieux
• Investigators: Principal Investigator: Keertan Dheda, Pr, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diagnosis; Tuberculosis; Bacterial infections; Mycobacterium infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: ISIT-TB 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No