Last reviewed · How we verify
New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis (TB-LIVE)
Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria. This inability to rule out living mycobacteria in patients investigated for LTBI leads to unnecessary and potentially harmful treatment regimes all around the globe. The goal of this observational study is to identify candidate biomarkers for viable bacilli in latent tuberculosis in order to decrease the use of unnecessary and ineffective antibiotic treatment.
Details
| Lead sponsor | Region Skane |
|---|---|
| Status | UNKNOWN |
| Enrolment | 130 |
| Start date | 2021-12-21 |
| Completion | 2024-12 |
Conditions
- Latent Tuberculosis
- Persistent Infection
- Mycobacterium Tuberculosis
Primary outcomes
- Cytokine levels — 0-12 months
To determine levels of selected cytokines in supernatants of Mtb-incubated whole blood obtained from persons diagnosed with LTBI during the course of treatment, and to identify patterns of cytokine expression suggestive of bacterial eradication. - Gene expression — 0-12 months
To characterize patterns of small non-coding RNA (sncRNA) expression (including microRNAs) in blood and plasma from persons diagnosed with LTBI, and to identify patterns of sncRNA expression in individuals with LTBI suggestive of bacterial eradication. - Activity of indoleamine 2, 3-dioxygenase (IDO) — 0-12 months
3\. To characterize IDO activity in plasma from persons diagnosed with LTBI, and to determine whether changes in IDO activity during the course of LTBI reflect bacterial eradication
Countries
Sweden