Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determine Dalbavancin Plasma Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration
研究概览
简要总结
This study will evaluate the pharmacokinetic properties of dalbavancin when administered as an intravenous infusion and instilled into the peritoneal space in patients who are undergoing peritoneal dialysis. The patients will receive intravenous dalbavancin followed by intensive plasma and peritoneal dialyses fluid sampling. Following a washout phase, the patients will then receive dalbavancin instilled into their peritoneal space followed by the same intensive plasma and peritoneal dialyses fluid sampling.
详细描述
This study is an open label, cross-over study, evaluating the plasma and peritoneal fluid pharmacokinetics (PK) of dalbavancin after either intravenous or intraperitoneal administration. In the first part of the study, ten patients will be administered dalbavancin on study day 0. Pharmacokinetic analysis will be conducted on days 0, 7, and 14. In the second part of the study, the same 10 patients will cross-over and then be administered dalbavancin on study day 0. Pharmacokinetic analysis will be conducted on days 0, 7, and 14.
Sample Size:
Ten (n=10) patients will be evaluated in this pharmacokinetic evaluation. Since this is a descriptive pharmacokinetic study a sample size calculation was not performed
Plasma and peritoneal fluid sampling:
Dalbavancin will be administered on study day 0. On the intravenous administration day dalbavancin will be administered as a 30-minute intravenous (IV) infusion. On the intraperitoneal administration day, dalbavancin will be administered in the peritoneal dialysis fluid with a 6 hour dwell time. On day 0, patients will undergo plasma and peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange. Patients will be given a specimen collection cup and asked to collect ~30 ml of peritoneal dialysate following scheduled nocturnal dwell approximately 24 hours following the administration of dalbavancin administration. Patients will report for a single PK measurement on study days 7 and 14. (18 total plasma and 18 total peritoneal fluid samples per patient). Blood samples will be drawn from a peripherally inserted intravenous catheter. Peritoneal fluid samples will be drawn from the already placed peritoneal dialysis catheter. Blood samples will be immediately centrifuged at 3000g and plasma and peritoneal fluid samples will be stored at -80°C until analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 to ≤89 years of age
- •Actively receiving chronic peritoneal dialysis
- •Ability and willingness to provide written informed consent
排除标准
- •Patients currently receiving antimicrobial therapy or have received antibiotic therapy within 14 days prior to study
- •Patients with known hypersensitivity reactions to dalbavancin or other glycopeptides
- •Prisoners
- •Pregnant or breastfeeding women
- •Decisionally challenged patients
研究组 & 干预措施
Dalbavancin via IV
Dalbavancin will be administered via intravenous administration. Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
干预措施: Dalbavancin via Intravenous Administration (Drug)
Dalbavancin via IP
Dalbavancin will be administered as an intraperitoneal administration. Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
干预措施: Dalbavancin via Intraperitoneal Administration (Drug)
结局指标
主要结局
Determine Dalbavancin Plasma Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration
时间窗: 14 days
14 day plasma concentrations
Determine Dalbavancin Peritoneal Fluid Area Under the Curve in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration
时间窗: 14 days
14 day peritoneal fluid concentrations
次要结局
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0(14 days)
- Determine Dalbavancin Peritoneal Fluid Clearance in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration(14 days)
- Determine Dalbavancin Plasma Clearance in Peritoneal Dialysis Patients After Intravenous and Intraperitoneal Administration(14 days)