Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 41
- 主要终点
- antibiotic concentration
研究概览
简要总结
This is a pilote monocentric prospective study about pediatric peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will include 41 patients between 3 and 17 years-old during 2 years in the University Hospital of Nancy.
The aim of this study is to determine if the beta-lactam dosages in children recommended by the guidelines for management of intra-abdominal infections permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.
The investigators will collected serum and peritoneal fluid samples at 3 different times: peritoneal incision, end of surgery, 2 days and 5 days after surgery in order to compare the concentrations and the minimal inhibitor concentration of bacteria.
The hypothesis is that of a serum and peritoneal antibiotic under dosage.
详细描述
Pediatric population with localized or generalized appendicular peritonitis with surgical management at the Nancy University Hospital.
Patients are usually taken in emergency at the Pediatric Emergency Department (Children's Hospital, CHRU Nancy). The diagnosis of peritonitis is then made or confirmed by clinical examination and paraclinical tests (biology and imaging).
Written informed consent is obtained from one of the parental authority holders, allowing inclusion in the study. An information document adapted to the child's understanding will also be sent to him/her. The child's non-opposition will be sought if he/she is old enough to understand. The information will be given jointly to the child and to the legal guardians present at the patient's bed at the time of diagnosis of peritonitis. The reflection period will correspond to the interval between this information and the management in the operating room. This may vary depending on the occupation of the operating room.
The diagnosis of appendicular peritonitis is made by the surgeon (routine care). The child is included.
Antibiotic therapy is started IV according to the protocol in force at the CHRU (routine care):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of intra-abdominal infection : localized or generalized peritonitis secondary to appendix
排除标准
- •betalactams allergy
- •peritonitis with other etiology than appendix
- •antibiotic treatment longer than 24h
结局指标
主要结局
antibiotic concentration
时间窗: During surgery, Day+2 after surgery if drain peritonal, Day+5 after surgery if systemic peritonitis,
Peritonal betalactams concentrations at different times
次要结局
- Determine Clearance or betalactams in children(Statistical analysis after 2 years of inclusion)
- Evaluate the relationship between serum and peritoneal concentrations of beta-lactam(Statistical analysis after 2 years of inclusion)
- Evaluation of duration of hospitalization(Statistical analysis after 2 years of inclusion)
- Determine Half-life(Statistical analysis after 2 years of inclusion)
- Determine elimination rate constant Kel(Statistical analysis after 2 years of inclusion)
- Proportion of sensitive and resistant germs to betalactam antibiotics(Statistical analysis after 2 years of inclusion)
- Factors associated with an antibiotic under-dosage(Statistical analysis after 2 years of inclusion)
- Factors associated with an antibiotic overdose(Statistical analysis after 2 years of inclusion)
- Determine distribution volume(Statistical analysis after 2 years of inclusion)
- Proportion of different bacteria(Statistical analysis after 2 years of inclusion)
- Description of minimal inhibition concentration for bacterias(Statistical analysis after 2 years of inclusion)
- Determine estimated initial concentrationf C0(Statistical analysis after 2 years of inclusion)
- Determine Area Under the Curve AUC.(Statistical analysis after 2 years of inclusion)
- Mean delay for apyrexia(Statistical analysis after 2 years of inclusion)
- Clinical complications(Statistical analysis after 2 years of inclusion)
研究者
Nicolas BERTE
Principal Investigator
Central Hospital, Nancy, France