Viromes in Infants Presenting With a Septic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Rate of detection of pathogenic viruses in nasal cavity samples
研究概览
简要总结
Fever in infants younger than 3 months is a common reason for emergency department visits and is associated with a significant risk of serious bacterial infections. Because it is difficult to distinguish bacterial from viral infections at presentation, management is often aggressive and includes invasive procedures, hospitalization, and empiric antibiotic therapy.
Despite advances in molecular diagnostics, the etiology of fever remains unidentified in a substantial proportion of cases. This study aims to assess the presence of pathogenic viruses in respiratory and intestinal samples from febrile infants younger than 3 months compared with afebrile controls, and to explore associations with clinical, biological, environmental, and socio-economic factors
详细描述
Fever in infants under three months of age is a high-stakes clinical condition because severe bacterial infections occur in up to 20-25% of cases, while clinical signs alone cannot reliably distinguish bacterial from viral illness. Due to immune immaturity, management is often aggressive, involving hospitalization, lumbar puncture, and intravenous antibiotics. Although molecular diagnostics (multiplex PCR), bacterial biomarkers (CRP, procalcitonin), and clinical algorithms have improved care, approximately one quarter of cases still lack a confirmed etiology-most often because viral infections are difficult to definitively establish.
This research project aims to improve etiological diagnosis in febrile young infants by systematically evaluating multiplex molecular tests and novel host-response biomarkers (including interferon-induced proteins) using minimally invasive nasal swabs. By correlating these results with final clinical diagnoses-classified as confirmed or probable viral or bacterial infections-the study seeks to clarify the role of these diagnostic tools in early infancy. Seasonal variations as well as environmental and socio-economic factors will be analyzed. A biological sample collection will be constituted for future analyses.The ultimate goal is to enhance diagnostic precision, reduce unnecessary hospitalizations and antibiotic exposure, and optimize the management of febrile infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Viral infections are epidemic and strongly seasonal. Therefore, we plan to include children during both the autumn-winter and spring-summer periods. Two groups will be constituted:
Period A (spring-summer): May 2 to August 31 - 50 febrile infants included. Period B (autumn-winter): October 1 to February 28 - 50 febrile infants included.
入排标准
- 年龄范围
- 0 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For participants :
- •Age < 3 months
- •Fever ≥38°C confirmed in pediatric emergency department
- •For control group :
- •Age < 3 months
- •Children requiring general anesthesia or managed in the pediatric emergency department, or during hospitalization or consultation, for a non-infectious condition requiring venipuncture
排除标准
- •For participants :
- •Lack of parental/legal guardian consent
- •Lack of affiliation with a social security scheme
- •Antibiotic treatment within 8 days prior to inclusion
- •For control group :
- •Lack of parental/legal guardian consent
- •Lack of affiliation with a social security scheme
- •Antibiotic treatment within 8 days prior to inclusion
- •Infectious episode within 8 days prior to inclusion
研究组 & 干预措施
Febrile infants
Infants under 3 months presenting with fever ≥38°C in the pediatric emergency department.
干预措施: biological samples (Biological)
Afebrile controls
Infants under 3 months without infectious symptoms undergoing non-infectious procedures requiring venous sampling or anesthesia
干预措施: biological samples (Biological)
结局指标
主要结局
Rate of detection of pathogenic viruses in nasal cavity samples
时间窗: Day 0
Proportion of infants with at least one pathogenic virus detected by multiplex RT-PCR in nasal cavity samples.
次要结局
- Comparison of viral detection rates between febrile infants and controls(Day 0)
- Comparison of viruses associated with fever in infants under 3 months of age according to the final diagnosis (viral-origin fever vs bacterial-origin fever) in nasal swabs and stool samples and/or perianal swabs(Day 0)
- Analysis of biological markers of inflammation(Day 0)
- Correlation between the presence and number of pathogenic viruses and environmental and socioeconomic factors.(Day 0)
- Establishment of a biological sample collection (biobank)(At the inclusion)