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临床试验/NCT05380869
NCT05380869已完成不适用

Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年4月1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
114
试验地点
2
主要终点
Description of outpatients with lower respiratory tract infection

研究概览

简要总结

Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. The primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (POCT) for procalcitonin (PCT) in identifying pneumonia as a bacterial infection in outpatients with LRTI.

详细描述

Lower respiratory tract infections (LRTI) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. Despite the vast majority of LRTI are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in LRTI still drives antibiotic treatment today Procalcitonin (PCT) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (POCT). The primary objective of the investigators study was to determine the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI. All patients aged 18 years or older with signs and symptoms of an LRTI as the leading diagnosis of the respiratory physicians are eligible. The medical assistant measure PCT from venous or capillary whole blood using the portable commercially available BRAHMS PCT direct point-of-care test (Thermo-Fischer Scientific). The stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. This immunoassay provides a quantitative result in 20 minutes. In suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. Members of the study team conduct standardised phone interviews of all participants on day 28.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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 older
  • Clinical diagnosis of lower respiratory tract infection

排除标准

  • Active malignancies
  • Cystic fibrosis
  • Solid organ or stem cell transplantation
  • Chronic infection (endocarditis, osteomyelitis, active tuberculosis)
  • Pregnancy

结局指标

主要结局

Description of outpatients with lower respiratory tract infection

时间窗: up to 5 weeks

The study population will be described in terms of demographic characteristics using descriptive statistics.

Determining the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI using portable commercially available BRAHMS PCT direct point-of-care test.

时间窗: up to 5 weeks

For the diagnostic accuracy of the PCT the receiver operating characteristic (ROC) curves and the area under the curve (AUC) will be calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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POCT PCT in Outpatient LRTI | 临床试验