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临床试验/NCT01951781
NCT01951781Unknown不适用

Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
153
试验地点
2
主要终点
proportion of negatives (healthy patient) which are correctly identified as such

研究概览

简要总结

Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns.

METHODS :

  • Monocentric prospective study including preterm newborn infants (<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France).
  • Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.
  • Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.

153 patients are needed in the study enrolled during a period of 12 months.

PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

年龄范围
— 至 5 Months(Child)
性别
All
接受健康志愿者

入选标准

  • preterm newborn (<37 weeks of gestationnal age )
  • undergoing symptoms of late-onset-sepsis
  • written informed consent obtained from the parents

排除标准

  • patient undergoing antibiotic therapy
  • patient undergoing surgery in the last seven days,
  • patient with severe congenital malformation
  • necrotizing enterocolitis
  • parents unable to understand the purpose of the study
  • no affiliation to social security

结局指标

主要结局

proportion of negatives (healthy patient) which are correctly identified as such

时间窗: day 1

次要结局

  • proportion of positives (sikness)which are correctly defined as such(day 1)
  • negative predictive CD64 value(day 1)
  • positive predictiveCD64 value(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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