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临床试验/NCT06981130
NCT06981130已完成不适用

Supporting Antibiotic Stewardship in Primary Care Via Point-of-care Testing (POCT) for Acute Respiratory Tract Infections: An Interventional Study

University of South Wales3 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2023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
144
试验地点
3
主要终点
Concordance between FebriDx result and clinician decision

研究概览

简要总结

Acute Respiratory Infections (ARIs) are a major contributor to antibiotic resistance, largely due to the over prescription of antibiotics driven by the subjective nature of clinical assessment. The ASPIRE II study aims to evaluate whether a Point-of-Care (POC) diagnostic test, utilising C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) biomarkers to differentiate between viral and bacterial infections can support clinical decision-making and serve as an effective antimicrobial stewardship tool.

详细描述

In the first ASPIRE study, in which the POC test was taken after the consultation, 20 participants produced results in the ratio 10:7:3 (negative, bacterial, viral) with a 75% agreement to the antibiotic prescription given by the physician following face-to-face consultation. The observational ASPIRE I Study identified the need for a rapid POC test and highlighted areas in which the test could have been used to prevent over-prescribing of antibiotics when ARI's are identified as viral. The FebriDx POC test was also useful in identifying instances where antibiotics were not prescribed, when a bacterial infection is presented, proving an effective decision-making tool for antibiotic stewardship.

Antibiotic stewardship is fast becoming an essential measure to improve antibiotic prescribing by clinicians. Antibiotic stewardship not only presents a cost-effective strategy for the NHS but addressed the issue of antimicrobial resistance (AMR) and protects patients from harm caused by unnecessary antibiotic use.

The economic costs of antibiotic resistance are largely unknown, but it is anticipated that with an increased number of cases, effects to the economy could be severe. Infections and infectious diseases cost England & Wales an estimated £30 billion a year, with many cases of acute respiratory infections (Chaplin, 2017). POC diagnostic tests in a clinical setting could give clinicians the ability to distinguish between microbial and viral infections, providing a more informed decision to antibiotic prescribing.

The purpose of this study is to build upon data generated by the ASPIRE study that determined by retrospective evaluation, that a POC immunoassay can accurately be used to guide clinician's prescription decision. The ASPIRE 2 study will use the POC assay as an interventional decision tool prior to the GP's consultation of a suspected acute respiratory infection (ARI).

Upon clinical assessment, the current clinical practice prescribes antibiotics based on symptoms reported by the patient and a subjective review by the GP. This results in antibiotics being prescribed from an informed decision made by the clinician, based only from patient symptoms. The use of a dual marker immunoassay could guide informed decisions based on qualitative data and degree of infection using POC testing in Primary Care.

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

  • Subject >18 years of age.
  • having new onset symptoms suggestive of acute respiratory infection (ARI within 7 days of seeking care: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath) with or without fever.

排除标准

  • Unable to provide informed consent.
  • Undergoing end of life care.
  • Immunocompromised or taking chemotherapy, oral steroids, or interferon.
  • Receiving a live vaccine in the last 14 days.
  • Taking antibiotics or antivirals in the last 14 days.
  • Patients that have symptoms lasting more than 7 days.

结局指标

主要结局

Concordance between FebriDx result and clinician decision

时间窗: End of recruitment period.

The level of agreement between the FebriDx classification (viral or bacterial) and the clinician's initial diagnostic impression and treatment decision, to prescribe antibiotics or not.

次要结局

  • Sensitivity and Specificity of FebriDx vs. Clinical Judgement(End of recruitment period .)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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