Biomarker-guided Diagnosis of Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of biomarker-guided diagnosis of TB - mRNA signatures
研究概览
简要总结
The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.
Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.
This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).
- •Age ≥ 18 years
- •Ability to provide informed consent
- •Willingness to participate in the study
排除标准
- •Lack of ability to provide informed consent
- •Age < 18 years
- •Pregnancy
结局指标
主要结局
Feasibility of biomarker-guided diagnosis of TB - mRNA signatures
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Feasibility of biomarker-guided diagnosis of TB - cellular immunology
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology.
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM.
Feasibility of biomarker-guided diagnosis of TB - EclLAM
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays.
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA.
Feasibility of biomarker-guided diagnosis of TB - MBLA
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA).
Feasibility of biomarker-guided diagnosis of TB - stool PCR
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Feasibility of biomarker-guided diagnosis of TB - composit
时间窗: From enrollment to the end of the first week of treatment
Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing.
次要结局
- Exploratory Analysis of Biomarker Profiles and Their Clinical Associations(From enrollment to the end of the first week of treatment.)
研究者
Thomas Theo Brehm
Dr. med.
Research Center Borstel