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临床试验/NCT05897801
NCT05897801已完成不适用

A CLINICAL STUDY OF THE MeMed BV® TEST TO DISTINGUISH BETWEEN BACTERIAL AND VIRAL INFECTIONS AND LIMIT GUT COLONIZATION BY MULTIDRUG RESISTANT MICROORGANISMS

Hellenic Institute for the Study of Sepsis3 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2023年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
230
试验地点
3
主要终点
The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test

研究概览

简要总结

The fast increase of Multidrug-resistant microorganisms (MDRO) due to the high amount of antimicrobials being poorly used may be limited by better regulating antimicrobial usage globally. The goal of this observational study is the performance of the MeMed BV® test in the MeMed Key® device at the emergency department to a) support the differential diagnosis between bacterial and viral infections of the respiratory tract and b) provide evidence of how the use of this test may limit gut colonization by MDRO.

详细描述

Antimicrobial resistance is one of the major threats to the society. One major driver of this phenomenon is the extensive use of antibiotics particularly during the winter months as empirical use for respiratory tract infections. Most of these infections, namely acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and acute bronchitis, are of viral origin and no antibiotics need to be prescribed. To limit the ambiguity of prescribing physicians leading them to unnecessary prescription of antibiotics, one new point-of-care test has been developed which may assist to distinguish between bacterial and viral infections.

This test is called MeMed BV® and is providing the integrative information of three measurable parameters in blood, namely TRAIL (tumour necrosis factor-related apoptosis-inducing ligand), IP-10 (interferon-gamma-induced protein-10) and CRP (C-reactive protein). TRAIL and CRP are increased in the case of bacterial infection; IP-10 is increased in viral infections; and the integrative algorithm suggests the likelihood for a patient to present with bacterial infection, with viral infection or to be at an intermediate state. Based on the results of the Appolo clinical study, the use of the MeMed BV® test which runs in the MeMed Key® device have been registered by the European Medicines Agency and by the Food and Drug Administration (FDA) of the United States for use in the Emergency department (ED) of differentiate between bacterial and viral infections.

The present study is aiming to the performance of the MeMed BV® test in the MeMed Key® device at the ED to a) support the differential diagnosis between bacterial and viral infections of the respiratory tract and b) provide evidence of how the use of this test may limit gut colonization by MDRO.

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

入选标准

  • Age 18 years or more
  • Both genders
  • Written informed consent provided by participants or their legal representatives
  • Symptoms compatible with the diagnosis of respiratory tract infection defined as at least one of: fever (core temperature more than or equal to 37.50C), chills, sore throat, myalgias, sudden onset of headache, running nose
  • Onset of symptoms the last 7 days

排除标准

  • Fever (core temperature more than or equal to 37.50C) for more than 7 days
  • Neutropenia defined as less than 1,000 neutrophils/mm3
  • Intake of chemotherapy for any malignancy
  • Intake of radiotherapy for any malignancy
  • Medical history of known active infection by the human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Pregnancy or lactation
  • Any acute trauma
  • Any operation the last 7 days
  • Presence of acute burns

结局指标

主要结局

The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test

时间窗: Through study completion, an average of 1 year

The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test

次要结局

  • The accurate prediction of the viral or the bacterial infection a patient is suffering from using the MeMed BV® test(Through study completion, an average of 1 year)
  • Exploratory endpoint(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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