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临床试验/NCT05354635
NCT05354635尚未招募不适用

Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
280
试验地点
1
主要终点
The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)

研究概览

简要总结

Currently, recommendations for antibiotic testing (ATS) in adult intensive care have been published. The 2018 SFAR and the Abdul- Aziz et al expert conference recommend routine testing for β-lactams, aminoglycosides, linezolid, and vancomycin and provide plasma concentration goals. No recommendations have been made for the pediatric intensive care unit (PICU) population. However, several articles report suboptimal plasma concentrations for the most frequently used antibiotics in PICU. The University Hospital of Reunion is the reference center for the western region of the Indian Ocean. This region presents a large mixed population due to the migratory flow, as well as a specific bacterial ecology. This suggests that the data already collected on antibiotic dosage in other European studies may not be fully extrapolated to Reunion Island.

It is in this context that we will study the plasma concentration of antibiotics for all children who received the most commonly used antibiotics (β-lactams, linezolid, vancomycin, and aminoglycosides) during their hospitalization in PICU.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Any child hospitalized in the pediatric intensive care unit of the CHU Nord de La Réunion,
  • Age is less than 18 years,
  • Having started a curative antibiotic therapy by β-lactam, linezolid, vancomycin or aminosides.
  • For whom a non-opposition has been collected orally from both or one of the child's legal guardians and from the child himself (if applicable),
  • Covered by Social Security.

排除标准

  • Patients on prophylactic antibiotic therapy

结局指标

主要结局

The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)

时间窗: 2 months

Underdosing is defined as a measurement of plasma concentration below the optimal therapeutic concentration (OTC)

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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