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临床试验/NCT07134751
NCT07134751尚未招募不适用

Febrile Infants Swedish Study

Region Skane10 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Region Skane
入组人数
2,000
试验地点
10
主要终点
The proportion of febrile infants aged ≤60 days with meningitis, bacteremia, and urinary tract infection identified by the new guideline and the proportion of those that received treatment with delay.

研究概览

简要总结

Approximately one million febrile infants aged ≤60 days present annually to pediatric emergency departments (PEDs) in Europe and the United States. Although fewer than 5% are diagnosed with meningitis or bacteremia (invasive bacterial infections - IBIs), and 10-15% with urinary tract infections (UTIs), current guidelines recommend extensive diagnostic evaluations, hospitalization, and empirical treatment with broad-spectrum parenteral antibiotics. This approach may contribute to medical overuse, with implications for patient care, healthcare resource utilization, and environmental sustainability.

The Febrile Infants Swedish Study (FISS) is a prospective observational study conducted across 11 PEDs in Sweden. All febrile infants aged ≤60 days presenting to participating sites will be eligible. A new clinical guideline for the management of infants with fever without source (FWS) will be implemented in 7 PEDs, while 4 PEDs will continue with current standard practice and serve as a comparison group.

The study is expected to run for approximately two years and aims to recruit a minimum of 2,500 febrile infants

详细描述

BACKGROUND

Each year, around one million febrile infants aged ≤60 days present to pediatric emergency departments (PEDs) in Europe and the United States. Previous studies report that 2-5% of these infants are diagnosed with meningitis or bacteremia (invasive bacterial infections - IBIs) and 10-15% with urinary tract infections (UTIs). Due to the potential severity of these infections, current guidelines recommend comprehensive diagnostic evaluations, hospitalization, and empirical treatment with broad-spectrum antibiotics. Consequently, an estimated 800,000 infants undergo these interventions annually without confirmed SBI.

These practices may have unintended consequences. Lumbar punctures can be painful, stressful, and time-consuming, with unsuccessful attempts linked to longer hospital stays. Early antibiotic exposure has been associated with increased risks of chronic conditions and reduced vaccine response and contributes to antimicrobial resistance. Hospitalization may lead to complications, disrupt breastfeeding, and impose financial and emotional burdens on families. Routine testing can result in overdiagnosis and medical overuse. Additionally, healthcare delivery has environmental implications, with each hospital bed-day generating significant waste and energy consumption.

Current guidelines rely on binary thresholds for biomarkers such as CRP and procalcitonin. They also lack consideration of clinical context, such as the infant's condition or fever characteristics, resulting in a uniform approach that may not suit individual cases.

There is a need for more individualized, evidence-based guidelines that integrate clinical and laboratory findings to support risk stratification and informed decision-making. Guidelines that reduce unnecessary interventions may improve care, optimize resource use, and lessen environmental impact.

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
— 至 60 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)
  • Age ≤60 days

排除标准

  • 未提供

结局指标

主要结局

The proportion of febrile infants aged ≤60 days with meningitis, bacteremia, and urinary tract infection identified by the new guideline and the proportion of those that received treatment with delay.

时间窗: 10 days of attendance

次要结局

  • The proportion of investigations, antibiotic treatments, and hospitalizations among febrile infants aged ≤60 days who visited the PED.(Day 1)
  • The prevalence of meningitis, bacteremia, and urinary tract infection among febrile infants aged ≤60 days.(10 days of attendance)
  • Duration and height of the fever, gestational age, birth weight, breastfeeding, clinical signs and symptoms, and laboratory results.(Day 1)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Orfanos Ioannis

MD, PhD, Senior Consultant Pediatrician

Region Skane

研究点 (10)

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