Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Readmission due to infection.
研究概览
简要总结
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.
详细描述
There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of individualized treatment duration in early-onset infection.
The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 35 weeks
- •Birth weight ≥ 2000
- •Probable or possible infection according to the structured infection risk assessment
- •Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment
- •Negative blood culture after 48 hours
排除标准
- •Infants with positive blood culture
- •Blood culture volume prior to antibiotics of < 0.2 ml
- •Site-specific infection as for example, meningitis or osteomyelitis
- •Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment
研究组 & 干预措施
Individualized treatment duration
Antibiotic treatment will be discontinued when both of the following two criteria are fulfilled:
- The infant has had 24 hours without clinical symptoms of infection, after systematic clinical evaluation by a neonatologist. Clinical symptoms specified in Table 1.
- CRP is < 30 mg/l. If CRP is > 30 at the time when the infant has been symptom-free for 24 hours, CRP will be assessed once every 24 -48 hours and antibiotics will be stopped when CRP < 30.
干预措施: Individualized treatment duration strategy (Other)
Standard treatment duration
Standard treatment duration is seven days.
结局指标
主要结局
Readmission due to infection.
时间窗: From 1-21 days after end of first course of antibiotic treatment.
Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment \> 72 hours
Death
时间窗: From 1-21 days after end of first course of antibiotic treatment.
Death of any cause
Total use of antibiotics
时间窗: From initiation of antibiotics and the next 28 days.
Use of antibiotics (in hours)
次要结局
- C-reactive protein (CRP)(CRP measured at follow-up 2 days after initial antibiotic treatment ended)
- Readmission due to infection within 3 months(From 1-100 days after first course of antibiotics ended.)
研究者
Ulrikka Nygaard
MD,Phd, Consultant, Associate Professor
Rigshospitalet, Denmark