Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Drug Clearance Due to Dialysis (CLdialysis)
研究概览
简要总结
The purpose of this study is to:
- Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
- Determine urine, HD and PD clearance of daptomycin.
详细描述
Infectious and sepsis events are one of the most common complications in children with chronic kidney disease. The incidence is highest in children with an access for dialysis, especially in those with catheters. Staphylococcal species account for more than 50% of access infections (ranging from 58-77%). Failure to clear the infection results in loss of dialysis access.
Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus, and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown.
Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
- •In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
- •Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
- •Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic
排除标准
- •Patients > 17 years of age
- •Patients < 12 years of age
- •Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
- •Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
- •Having used daptomycin in the 30 days preceding study entry
- •Participating in any experimental procedure in the 30 days preceding study
- •A history of muscular disease or neurological disease
- •Baseline creatine phosphokinase (CPK) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 IU/L)
- •Hemoglobin < 9 g/dl
- •Hemodynamic instability within 72 hours before study enrollment
- •Female subjects with a positive pregnancy test or failure to take a pregnancy test
研究组 & 干预措施
Daptomycin
Pediatric patients on hemodialysis or peritoneal dialysis with suspected or confirmed infection and who were receiving standard of care antibiotics were also eligible to receive a single dose of daptomycin 5mg/kg IV. Serial blood draws were obtained to assess daptomycin pharmacokinetics
干预措施: Daptomycin (Drug)
结局指标
主要结局
Drug Clearance Due to Dialysis (CLdialysis)
时间窗: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The rate at which a drug substance is removed from the body due to dialysis therapy
Volume of Distribution at Steady State (Vss)
时间窗: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Elimination Rate Constant (Ke)
时间窗: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Maximum Plasma Concentration (Cmax)
时间窗: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
时间窗: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
时间窗: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
时间窗: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose
Total Drug Clearance (CLtotal)
时间窗: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose
The rate at which a drug substance is removed from the body
次要结局
未报告次要终点