Impact of a New Sequential Approach on Antimicrobial Use in Young Children With Fever Without Source in Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,928
- 试验地点
- 27
- 主要终点
- Change in antibiotics exposure
研究概览
简要总结
Because a newly available point-of-care test may have real interest especially for children in the Emergency Department (ED) setting, by limiting painful and stressful venipunctures and decreasing the length of stay in the ED, the investigators hypothesize that integrating this new capillary Procalcitonin (PCT) rapid test in the DIAFEVER CPR (Clinical Prediction Rules) could represent a highly valuable diagnostic tool to identify a group with low Invasive Bacterial Infection (IBI) risk and could limit unnecessary exams and antibiotic prescriptions. The aim of this present study is to demonstrate the impact of this new PCT rapid-test-based CPR on antibiotic prescription rate in young children with Fever Without Source (FWS) presenting to the ED and on morbidity and mortality
详细描述
This prospective multicentric randomized study will include 5000 febrile children aged six days to three years, diagnosed with fever without source, in 26 participating French and Swiss emergency departments, during a 36-month period.
During one period, all children will receive usual care. In a second period, the DIAFEVER algorithm will be applied in half of the clusters, and in the remaining clusters, children will still receive usual care.
Then in the last period of one year, all centers will apply the new PCT-based algorithm.
At day 15 after the first consultation, data concerning death, intensive care unit admission, disease-specific complications, diagnosis of bacterial infections and proportion of antibiotic treatments will be assessed by questioning parents by use of an online electronic case report form or a phone call. The endpoints will be compared between the two groups by using a mixed logistic regression model adjusted on clustering of participants within centers and period within centers.
To perform complementary studies, a biocollection will be proposed to parents when blood tests will be indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Days 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Febrile children aged 6 days to <36 months old presenting to an ED at their initial visit with an acute illness for a maximum of 8 days and diagnosed with a FWS defined as body temperature (measured at home or the ED) > 38°C and a physical examination by a physician without source
- •Oral non-opposition will be requested from one of the parents or caregivers of the patient.
- •No current antibiotic treatment or within the 48 hours before the ED presentation.
- •Parental affiliation with an appropriate health insurance system
- •Parents speaking French
排除标准
- •A clear source of fever identified after a careful inspection of medical history and a physical examination
- •No fever on consultation or previously subjectively assessed by parents without use of a thermometer
- •Refusal of the parents to participate
- •Child ≥ 36 months or < 6 days old (ie, early-onset neonatal infection)
- •Ongoing ABT treatment or within the 48 hours before ED presentation
- •Children with FWS who revisited the ED after their initial visit
- •Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects
研究组 & 干预措施
Usual care
Local usual management of FWS (pragmatic approach)
DIAFEVER algorithm
New DIAFEVER sequential algorithm PCT rapid test-based will be applied
干预措施: DIAFEVER algorithm (Diagnostic Test)
结局指标
主要结局
Change in antibiotics exposure
时间窗: at day 15 after the first ED consultation
Related to the superiority objective : change in antibiotics exposure based on the proportion of children who received ABT
次要结局
- Impact of the DIAFEVER prediction rule on median length of stay in the ED(at day 15 after the first ED consultation)
- Impact of the DIAFEVER prediction rule on hospitalization rates(at day 15 after the first ED consultation)
- Description of the current epidemiology of FWS among children < 36 months old admitted in an ED(At inclusion visit)
- morbidity and mortality(at day 15 after the first ED consultation)
- Diagnostic value of the DIAFEVER prediction rule for SBI and IBI diagnosis(At inclusion visit)
- Impact of the DIAFEVER prediction rule on the proportion of children with laboratory tests prescription(at day 15 after the first ED consultation)
- vaccine coverage of children consulting for FWS evaluated by the vaccination coverage rate (among children with FWS)(at day 15 after the first ED consultation)
- theoretically vaccine-preventable SBI(at day 15 after the first ED consultation)