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Completed

NCT Number: NCT04995406

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

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

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cape Town Lung Institute

Cape Town, 7700, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Evaluation of performance of the diagnostic tool

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BioMérieux

Industry

Registry information

Official study 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

Acronym: ISIT-TB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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