Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy
研究概览
简要总结
The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB therapy duration in neonates with LOS.
Our hypothesis is that the use of procalcitonin guidance can reduce of 30% the duration of ATB treatment without increasing recurrence of infection and mortality.
详细描述
Randomized controlled multicenter open trial comparing the efficacy of PCT guided strategy (superiority aspect) and safety (non-inferiority aspect) versus usual strategy in LOS of the neonate.
After inclusion, patients are randomly assigned (in a 1:1 ratio) to duration of ATB therapy according to PCT guidance (experimental group) or to standard of care (control group).
Experimental group:
For patients randomly assigned in the PCT-guided group, a PCT concentration is measured at D0 (randomisation), at D2 and then, every two days until PCT value is equal or below 0.5 ng/mL.
The physician in charge of the neonate will be strongly encouraged to stop ATB treatment as soon as the PCT value is equal or below 0.5 ng/mL.
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
- 96 Hours 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born at 24 or more weeks of gestation,
- •Aged over 96 hours of life, i.e. from the 5th day of life and less than 45 gestational weeks at diagnosis of assumed or proven LOS,
- •Weight at the inclusion ≥ 700 g,
- •Treated by ATB therapy for less than 48 hours,
- •When the physician decides to continue de empiric ATB treatment beyond the initial 48-h period,
- •Written informed consent signed by both parents (in the absence of one of the two parents the day of inclusion, the new born can be included with the signature of only one parent.The second parent must give oral consent and sign the consent form as soon as possible "before day 28"),
- •Affiliation to a social security system (recipient or assign).
排除标准
- •Neonates with non-indication of ATB treatment following the 48h-initial empiric period.
- •ATB treatment within the 48h before the current episode of infection; except for taking antibiotics for prophylactic purposes (ex: digestive decontamination), pulmonary-targeted treatments for atypical germs and antibiotics by local means (ex.: eye drops).
- •Patients diagnosed with severe infections (meningitis and/or septic shock) or needing prolonged therapy (ex: endocarditis, bone infection, deep seated infection, abscesses). Septic shock is defined by fluid resistant hypotension requiring vasopressor therapy.
- •Infections not contracted during the hospitalization in the neonatal period or revealed more than 48 hours after hospital discharge.
- •Neonates during treatment by extracorporeal membrane oxygenation or extra-corporeal circulation, and within the 72h after the end of the treatment.
- •Neonates previously included in the Proabis study.
- •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
PCT-guided strategy
Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.
干预措施: PCT dosage (Procedure)
Usual practice (control group)
Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice.
结局指标
主要结局
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy
时间窗: up to 28 days
Number of days between start and end of treatment, including treatment of the recurrence, if any
次要结局
- Non-inferiority of the PCT-guided ATB strategy to usual strategy on mortality at 28 days following randomization(28 days)
- To compare the cumulative dose of received ATB treatment (mg/kg).(Day 28)
- To describe the bacteriological epidemiology of LOS(28 days)
- Proportion of patients with bronchopulmonary dysplasia(28 days)
- Non-inferiority of the PCT-guided ATB strategy to usual strategy on recurrence of infection within 72 hours after ending ATB therapy.(28 days)
- Description on the total number of assumed or proven bacterial infections within the 28 days following randomization.(28 days)
- Proportion of patients with at least one event between randomization and day 28 among death, recurrence of infection and bronchopulmonary dysplasia.(28 days)
- Antibiotics free days at D28(28 days)