Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
NCT ID: NCT04995406
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
722 participants
OBSERVATIONAL
2022-01-03
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Active TB ATB
Participants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity
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
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
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.
ISIT-TB prototype
Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour
Interventions
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ISIT-TB prototype
Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour
Eligibility Criteria
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Inclusion Criteria
* 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
* A person who has received treatment for active TB or LTBI in the past 24 months
18 Years
ALL
Yes
Sponsors
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BioMérieux
INDUSTRY
Responsible Party
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Principal Investigators
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Keertan Dheda, Pr
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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University of Cape Town Lung Institute
Cape Town, , South Africa
Countries
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Other Identifiers
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ISIT-TB 001
Identifier Type: -
Identifier Source: org_study_id
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