A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 940
- 主要终点
- Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.
研究概览
简要总结
Tuberculosis (TB) is a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health. TB-SPECTRUM project will conduct a clinical study to characterize better clinically, microbiologically, and immunologically the spectrum of TB across the different stages of infection, including incipient and asymptomatic/subclinical TB, active disease, and post treatment phases. Passive and active case-finding (ACF) clinical approaches will be implemented, recruiting TB patients through public and private healthcare facilities and targeted community outreach, as well as their close contacts. This approach will allow the study of biomarker profiles associated with infection risk, disease progression and response to treatment. The specific objectives of the study will be:
- To unravel immune mechanisms underlying the TB spectrum through a multidisciplinary approach.
- To perform a clinical study (passive and ACF) for recruiting patients and their contacts for the enrolment of incipient/subclinical TB forms and the subsequent immune characterization and management.
- To characterize host systemic and local immune responses on different TB immune states (with special focus on incipient, subclinical and cured TB) to better understand host-pathogen interactions and the established cellular/humoral immune mechanisms.
- To stratify host immunity according to patient's clinical strain characterization and disease severity.
- To develop and evaluate innovative tools for better management of all phases of the TB spectrum.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 5 and 65 years
- •Willing and able to provide informed consent (or legal guardian consent) *GROUP 1: Active pulmonary TB*
- •Bacteriologically confirmed TB
- •Pulmonary TB
- •Anti-TB treatment ≤ 14 days *GROUP 2: Close contacts of active pulmonary TB*
- •Close contact with confirmed pulmonary TB case
- •Exposure ≥6 hours/day for ≥5 days/week
- •Positive TST and/or IGRA
- •NOT receiving TB preventive therapy *GROUP 3: Other respiratory diseases (non-TB)*
- •Diagnosis of ARI (Acute Respiratory Infection) and/or sarcoidosis and/or lung cancer
- •Clinical/radiological findings consistent with non-TB disease
- •NO clinical suspicion compatible with active TB *GROUP 4: Healthy uninfected controls*
- •No symptoms suggestive of active TB
- •Not known prior exposure to active TB
- •Negative TST and/or IGRA
排除标准
- •Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)
- •Known or suspected pregnancy
结局指标
主要结局
Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.
时间窗: Close contacts (group 2) recruited in clinical sites (IPMN, IPCD, BHU and SSCC) and followed at baseline, 3 months and 12 months with clinical assessments and samplings. And symptoms will be monitored remotely by phone up to 24 months after enrollment.
Characterization of treatment monitoring and cured TB across the TB-SPECTRUM assesed by clinical, immunological, microbiological and molecular assays.
时间窗: Clinical assesments and sampling will be done in active TB cases (Group 1) at month 2, 6, and post-treatment (2-6 months after treatment).
次要结局
未报告次要终点
研究者
Irene Latorre Rueda
Senior Researcher
Fundació Institut Germans Trias i Pujol