TUBERCULOSIS, PULMONARYISIT-TBNCT04995406
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
An observational study of TUBERCULOSIS, PULMONARY, run by BioMérieux at 1 site in South Africa.
Trial summary
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- TUBERCULOSIS, PULMONARY
- What is being tested?
- ISIT-TB prototype
- How many people
- 722 participants
- Where
- 1 siteSouth Africa
- Study dates
- 3 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant woman
- A person who has received treatment for active TB or LTBI in the past 24 months
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Cape Town Lung Institute
Cape Town, 7700
About this study
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
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
Read the 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.
- Conditions
- TUBERCULOSIS, PULMONARY
- Being tested
- ISIT-TB prototype
- Keywords
- Tuberculosis, Mycobacterium infections, Bacterial infections, Diagnosis
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Mycobacterium Infections, Bacterial Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIT-TB prototypeDiagnostic test
Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour
| Study group | Role | What they receive |
|---|---|---|
| Active TB ATB | Participants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity Receives: Diagnostic Test: ISIT-TB prototype | |
| Latent Tuberculosis Infections LTBI | Participants with presumed latent TB infection Receives: Diagnostic Test: ISIT-TB prototype | |
| Healthy controls HC | Participants who do not have Active or Latent tuberculosis or other pathologies investigated in this study Receives: 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. Receives: Diagnostic Test: ISIT-TB prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time to bacteriological confirmation 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start3 Jan 2022
- Primary completion1 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TUBERCULOSIS, PULMONARYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keertan Dheda, Pr, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995406
- Sponsor's protocol ID
- ISIT-TB 001
- Acronym
- ISIT-TB
- Status last verified
- Mar 2024
- First submitted
- 2 Aug 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04995406
- Acronym / sponsor ID
- ISIT-TB / ISIT-TB 001
- Conditions
- TUBERCULOSIS, PULMONARY
- Keywords
- Tuberculosis, Mycobacterium infections, Bacterial infections, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active TB ATB | – | Diagnostic Test: ISIT-TB prototypeParticipants with active tuberculosis with diagnosis confirmed by GeneXpert and/or culture positivity |
| Latent Tuberculosis Infections LTBI | – | Diagnostic Test: ISIT-TB prototypeParticipants with presumed latent TB infection |
| Healthy controls HC | – | Diagnostic Test: ISIT-TB prototypeParticipants who do not have Active or Latent tuberculosis or other pathologies investigated in this study |
| Non-tuberculous symptomatic participants | – | Diagnostic Test: ISIT-TB prototypeThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant woman
- A person who has received treatment for active TB or LTBI in the past 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIT-TB prototypeDiagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour | Diagnostic test | Active TB ATB, Healthy controls HC, Latent Tuberculosis Infections LTBI, Non-tuberculous symptomatic participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keertan Dheda, Pr principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TUBERCULOSIS, PULMONARY, run by BioMérieux at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of performance of the diagnostic tool (time frame: Time to bacteriological confirmation 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.