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临床试验/NCT02025699
NCT02025699已完成不适用

Observational Multi-center, Prospective Study to Characterize Novel pathogen-and Host-related Factors in Hospitalized Patients and Patients on the Emergency Department Presenting With Lower Respiratory Tract Infections and/or Sepsis.

MeMed Diagnostics Ltd.1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,200
试验地点
1
主要终点
Sensitivity and specificity for a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis

研究概览

简要总结

The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.

详细描述

The TAILORED-Treatment consortium was established to develop new tools aimed to increase the effectiveness of antibiotic and antifungal therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults.

In reality, targeted antimicrobial therapy can most effectively be achieved by utilizing personalized data to facilitate a tailored and optimized approach to individual patient treatment. This can best be achieved by utilizing knowledge gained from both host-centered and pathogen-centered parameters during health and disease. Unfortunately, these parameters have traditionally, tended to be measured independently (for example using microbial culture or PCR-based methods for microbial detection, or measurement of the immune response to infections and/or blood-based biomarkers in the host), and used on an ad hoc basis without careful integration for the best treatment of the patient. However, recent advances in the development of high-throughput and sensitive molecular-based technologies, on-line internet database access tools, and bioinformatics analysis, now means that the goal of personalized medicine and treatment is in sight. Unfortunately however, there currently exists a technological gap between recent state-of-the-art methodologies (for example with respect to gaining new insights into novel host-pathogen interactions) and laboratory-to-bedside results to benefit patients, physicians and society as a whole. The TAILORED-Treatment project is designed to bridge this technological gap in order to generate novel insights and innovations that are readily exploitable for the maximum benefit of multiple stakeholders in the field of personalized medicine and infectious diseases.

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
1 Month 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • An episode of febrile infection during the past 3 weeks
  • A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
  • Presence of obvious alternative causes of respiratory distress, such as heart failure or pneumothorax
  • Patients with a nosocomial LRTI (developed > 3days after hospitalization)
  • Post-transplant patients
  • Congenital immune deficiency (CID)
  • Active hematological malignancy
  • Current treatment with immune-suppressive or immune-modulating therapies including:
  • Chemotherapy, Radiotherapy or High dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks, Monoclonal antibody or Intravenous IgG (IVIG), Cyclosporine, Anti-TNF agents, Interferon (of all kinds)
  • Other severe illnesses that affect life expectancy and quality of life such as: Moderate to severe psychomotor retardation Moderate to severe congenital metabolic disorder
  • In children only: Other severe illnesses affecting life expectancy less than one year.

结局指标

主要结局

Sensitivity and specificity for a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis

时间窗: 4 years

The assesment of the sensitivity and specificity of a multi-parametric diagnostic model, incorporating different pathogen- and host-related factors, in differentiating between bacterial and viral etiology in patients with LRTI and/or sepsis

次要结局

  • Sensitivity and specificity ≥70% for liquid chromatography-mass spectrometry and lipid-based Protein Immobilization proteomics-based rapid detection technique in identifying pathogens in clinical samples of patients with LRTI and/or sepsis(4 years)
  • A list of significant bacterial microbiome components that are associated with poor or favorable clinical outcome in patients with LRTI and/or sepsis(4 years)
  • Sensitivity and specificity ≥70% for host-related individual biomarkers, in differentiating bacterial or viral or fungal etiology from other etiologies in patients with LRTI and/or sepsis(4 years)
  • Sensitivity and specificity ≥70% for sets of blood biomarkers, in differentiating Gram positive or Gram negative or atypical etiology from other disease etiologies in patients with LRTI and/or sepsis(4 years)
  • Monitoring the temporal dynamics concentrations of blood biomarkers levels during the course of disease in patients with LRTI and/or sepsis(4 years)
  • To build a web-based application that provides physicians with a recommended antimicrobial treatment based on patients clinical, molecular and biochemical data.(4 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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