Clinical Usefulness of a Multi-analyte Immunoassay for Distinguishing Bacterial and Viral Infections in a Cohort of Pediatric Febrile Patients
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
- 否
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
Elisabetta Venturini
MD
Meyer Children's Hospital IRCCS
