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NCT05621343Completed

New Strategies for Assessment of the Persistence of Viable Bacilli in Latent and Active Tuberculosis

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
89 (actual)
First submitted
10 Nov 2022
Start date
21 Dec 2021
Primary completion date
1 Dec 2025
Lead sponsor
Region Skane
Diseases
Tuberculosis
NCT number
NCT05621343

What you commit to

  • Study type: Observational
  • Participants enrolled: 89
  • From 21 Dec 2021 to the primary completion date, 1 Dec 2025
  • 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 design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous treatment for either active or latent TB infection
    • Controls
  • previous treatment for either active or latent TB infection
    • Active TB

Other illness

  • active tuberculosis
  • chronic illness
  • latent- OR active tuberculosis
  • chronic illness

Age

  • age \< 15 years

Other

  • immunosuppressive treatment
  • pregnancy (including 6 months post-partum)
  • immunosuppressive treatment
  • pregnancy (including 6 months post-partum)

Who the study is looking for

  • 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
  • age 15-25 years
  • informed consent
  • diagnosed with active TB
  • informed consent

Criteria the registry did not label

  • LTBI (2 groups)

Age in the registry: 15 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Skåne University Hospital
Coordinator of this site? Confirm its status
MalmöSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.