Which Virus Leads to Viremia in Children With Fever Without Source and do New Biomarkers Correlate With Viral and Bacterial Infections?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy compared to expert panel for bacterial versus viral.
研究概览
简要总结
The study is an observational blinded Validation study in pediatric patients below 3 years old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to validate the performance of a proteomic signature aiding the physicians to discriminate between viral and bacterial infections in febrile children. The study will also assess the prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study cohort.
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
- 1 Day 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of FWS (fever of less than 7 days with no cause determined by the history or the physical exam)
- •Age < 3 years old
- •Informed consent (IC) given by parent or legal guardian
排除标准
- •Unavailable blood
- •Comorbidities predisposing to infections such as cancer, primary or secondary immunodeficiency, and iatrogenic immunosuppression
- •Inclusion Criteria for healthy controls:
- •Age < 3 years old
- •Informed consent (IC) given by parent or legal guardian
- •No suspicion of infectious or inflammatory disease at presentation and during the two weeks before.
结局指标
主要结局
Diagnostic accuracy compared to expert panel for bacterial versus viral.
时间窗: 0-7 days after initiation of symptoms
Sensitivity, specificity, NPV and PPV were measured for ImmunoXpert and Labscore. The proteomic signature is a combination of different markers including: tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (pg/mL), interferon γ-induced protein-10 (IP-10) (pg/mL) and C-reactive protein (CRP) (mg/L). The proteomic signature is expressed as a score (no units. ranges 0-100). The Labscore is a combination of procalcitonin (ng/mL), C-reactive protein (CRP) (mg/L) and urinary dipstix (positive if presence of leucocyturia or nitrites). The Lab-score is expressed as a score (no units. ranges 0-9)
次要结局
- Comparison of biomarker levels in patients with different etiologies as classified by the expert panel or healthy.(0-7 days after initiation of symptoms in cases with infection.)
- Prevalence of viruses in children with fever without source.(0-7 days after the initiation of symptoms)
- Diagnostic accuracy compared to microbiology gold standard for ruling out invasive bacterial infection.(0-7 days after initiation of symptoms)