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

NCT04995406 | Completed

• 1 other identifier: ISIT-TB 001
• Study Type: observational
• Target: 722
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

TUBERCULOSIS, PULMONARY

Keywords

Tuberculosis; Mycobacterium infections; Bacterial infections; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Active TB ATB

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

Diagnostic Test: ISIT-TB prototype

Latent Tuberculosis Infections LTBI

Participants with presumed latent TB infection

Diagnostic Test: ISIT-TB prototype

Healthy controls HC

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

Diagnostic Test: ISIT-TB prototype

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

Interventions

ISIT-TB prototype DIAGNOSTIC_TEST

Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour

Active TB ATB; Healthy controls HC; Latent Tuberculosis Infections LTBI; Non-tuberculous symptomatic participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (1)

University of Cape Town Lung Institute

Cape Town, 7700, South Africa

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis; Mycobacterium Infections; Bacterial Infections; Disease

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keertan Dheda, Pr

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: January 3, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)