Assessing viable bacteria in latent and active tuberculosis
New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis
This study is trying to find out if certain blood markers can help tell if people with latent tuberculosis actually have live bacteria, so they can avoid unnecessary antibiotic treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 15 Years to 100 Years |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Malmö, Skåne) |
| Trial ID | NCT05621343 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers that indicate the presence of viable Mycobacterium tuberculosis in patients with latent tuberculosis infection (LTBI). By analyzing blood samples over a treatment period of 4-6 months and during a one-year follow-up, the study will compare cytokine levels, enzyme activity, and gene expression changes among patients with LTBI, active TB, and healthy controls. The goal is to reduce unnecessary antibiotic treatments for patients who do not harbor live mycobacteria, thereby improving patient care and outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15-25 with a positive interferon gamma release assay indicating latent tuberculosis.
Not a fit: Patients with active tuberculosis or those who have previously received treatment for TB will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and reduce the incidence of unnecessary treatments for latent tuberculosis.
How similar studies have performed: While there have been studies on biomarkers in tuberculosis, this specific approach to distinguishing viable bacilli in LTBI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
LTBI (2 groups) Inclusion Criteria: * latent tuberculosis: Interferon gamma (IFN-γ) \>0.70 IU/ml in the Quantiferon-TB Plus assay * age 15-25 years OR high likelihood of recent TB transmission * informed consent Exclusion Criteria: * active tuberculosis * chronic illness * immunosuppressive treatment * pregnancy (including 6 months post-partum) * previous treatment for either active or latent TB infection Controls Inclusion Criteria: * age 15-25 years * informed consent Exclusion Criteria: * latent- OR active tuberculosis * chronic illness * immunosuppressive treatment * pregnancy (including 6 months post-partum) * previous treatment for either active or latent TB infection Active TB Inclusion Criteria: * diagnosed with active TB * informed consent Exclusion Criteria: age \< 15 years
Where this trial is running
Malmö, Skåne
- Skåne University Hospital — Malmö, Skåne, Sweden (Recruiting)
Study contacts
- Principal investigator: Per Björkman, Professor — Lund University, Faculty of Medicine, Department of Translational Medicine
- Study coordinator: Petter Holmberg, PhD student
- Email: petter.holmberg@med.lu.se
- Phone: +4640333108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.