Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.
研究概览
简要总结
Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.
详细描述
Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months - 17 years
- •Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture)
- •VPS is externalized and External Ventriculostomy Drain (EVD) is in place
- •Patient has IV access and is receiving antibiotic treatment for VPS infection
- •Parent/Guardian signed written informed consent
- •Negative urine or serum pregnancy test for females of child-bearing potential
排除标准
- •Known Allergy to beta-lactam antibiotics
- •Moderate to severe renal impairment (Creatinine clearance < 50mL/minute)
- •Parent/Guardian written consent cannot be obtained
- •Positive urine or serum pregnancy test
研究组 & 干预措施
Arm 1
Single dose IV ceftaroline will be administered
干预措施: Ceftaroline (Drug)
结局指标
主要结局
Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.
时间窗: 8 hours
Serial collection of three blood and three cerbrospinal fluid sample over 8 hours
次要结局
未报告次要终点
研究者
Basim Asmar
Professor of Pediatrics
Wayne State University