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临床试验/NCT05621343
NCT05621343招募中不适用

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

Region Skane1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
130
试验地点
1
主要终点
Gene expression

研究概览

简要总结

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.

详细描述

Tuberculosis (TB) is the second leading cause of death due to a single infectious agent, with the main burden in resource-limited settings and in vulnerable populations. It is estimated that approximately 25% of the global population is infected with TB. LTBI is a condition where the mycobacteria rests within the body instead of creating active disease. About half of the active TB cases develop within 2 years of exposure and the other half reactivates as distant as several decades post exposure. Persistence of viable bacilli is a prerequisite for the reactivation of TB.

Through sampling of peripheral blood the investigators will investigate how selected cytokines, enzyme activity and gene expression changes during course of treatment, 4-6 months, and during follow up, 1 year. These patterns will be compared to the patterns of patients with: latent TB without treatment, active TB with treatment as well as healthy controls. Samples will be drawn at 0, 1, 6 and 12 months, after treatment initialization when applicable. Healthy controls will only be sampled once. Most of the analysis will be performed on TB-antigen stimulated blood.

The investigators hypothesize that there is a substantial fraction of latent TB patients who do not harbor live mycobacteria and that this is reflected in study outcome measures when given treatment. Furthermore, the investigators hypothesize that this fraction of latent TB patients will resemble healthy controls in terms of outcome measures whereas their counterpart, latent TB patients harboring living bacteria, will not.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • active tuberculosis
  • chronic illness
  • immunosuppressive treatment
  • pregnancy (including 6 months post-partum)
  • previous treatment for either active or latent TB infection
  • 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
  • Inclusion Criteria:
  • diagnosed with active TB
  • informed consent
  • Exclusion Criteria:
  • age < 15 years

结局指标

主要结局

Gene expression

时间窗: 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.

Cytokine levels

时间窗: 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.

Activity of indoleamine 2, 3-dioxygenase (IDO)

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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