RecruitingNCT05621343

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


Sponsor

Region Skane

Enrollment

130 participants

Start Date

Dec 21, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 15 YearsMax Age: 100 Years

Inclusion Criteria8

  • LTBI (2 groups)
  • 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

Exclusion Criteria13

  • active tuberculosis
  • chronic illness
  • immunosuppressive treatment
  • pregnancy (including 6 months post-partum)
  • previous treatment for either active or latent TB infection
  • Controls
  • 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
  • age < 15 years

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Locations(1)

Skåne University Hospital

Malmo, Skåne County, Sweden

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NCT05621343


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