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临床试验/NCT06852846
NCT06852846进行中(未招募)不适用

Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in a Cohort of Pediatric Febrile Patients

Meyer Children's Hospital IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Percentage of patients with concordance between biochemical test result and clinical diagnosis

研究概览

简要总结

Fever can be a clinical manifestation present in pediatric infections, posing a challenge for the doctor who must decide whether or not to prescribe an antibiotic therapy. Routine blood tests can assist the doctor in making a decision, although their response times often do not allow for timely therapeutic decisions. Therefore, there is an increased risk of inappropriate prescribing antibiotics for children with viral infections, which contributes to the increase in antibiotic resistance. There is evidence suggesting the effectiveness of certain biomarkers in distinguishing viral from bacterial forms. Biomarkers of potential interest include tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), interferon gamma-inducible protein of 10 kDa (IP-10), and C-reactive protein. The combination of those tests could distinguish between bacterial and viral infections with 90-94% sensitivity, 88-92.8% specificity, 59-81% positive predictive value and 97-98.8% negative predictive value. This is prospective study using biological samples that aims to evaluate the best diagnostic algorithm for obtaining an early and accurate etiological diagnosis (bacterial infection vs viral infection) of a febrile pediatric patient presenting at the Emergency Department, by comparing the standard algorithm with the diagnostic algorithm integrated with the results of the multi-analytic test.

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
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 3 months and < 18 years
  • Access to the Emergency Department during the study period
  • Fever (body temperature ≥38°C) for less than 7 days
  • Absence of an infectious focus or symptoms affecting the respiratory tract

排除标准

  • Fever for more than 7 days
  • Antibiotic therapy for ≥ 48 hours
  • Acute gastroenteritis
  • HBV (hepatitis B virus) or HCV (hepatitis C virus) infection
  • Active oncologic pathology
  • Metabolic pathology
  • Trauma or major surgery within the past 7 days

结局指标

主要结局

Percentage of patients with concordance between biochemical test result and clinical diagnosis

时间窗: From the date of enrollment to the date of diagnosis

次要结局

未报告次要终点

研究者

发起方
Meyer Children's Hospital IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabetta Venturini

MD

Meyer Children's Hospital IRCCS

研究点 (1)

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