NCT04995406Completed
Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis
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
Source: ClinicalTrials.gov · Last updated 8 Mar 2024
Brief summary (registry, in English)
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 722 (actual)
- First submitted
- 2 Aug 2021
- Start date
- Jan 2022
- Primary completion date
- May 2023
- Lead sponsor
- BioMérieux
- Diseases
- Tuberculosis
- NCT number
- NCT04995406
What you commit to
- Study type: Observational
- Participants enrolled: 722
- From Jan 2022 to the primary completion date, May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A person who has received treatment for active TB or LTBI in the past 24 months
Other
- Pregnant woman
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Lung Institute Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.