Pharmacokinetics of Cidofovir During Continuous Venovenous Hemofiltration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- AreaUnderCurve (AUC)
研究概览
简要总结
Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis in patients with AIDS and as a second line therapy for HCMV infections not responding to ganciclovir or foscarnet.
In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established extracorporal renal replacement therapy with a high clearance rate.
Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used.
Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir during CVVH in critically ill patients. It is suspected that Hemofiltration will influence cidofovir plasma levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Suspected of proven HCMV infection
- •Suspected or proven resistancy of HCMV to the first line therapy (ganciclovir / foscarnet).
- •Continuous venovenous hemodiafiltration (CVVHDF) due to acute or chronic renal failure.
排除标准
- •Known history of hypersensitivity to cidofovir or probenecid.
- •An expected survival of less than three days.
- •Known alcohol dependency, epilepsy, pregnancy or liver failure.
- •Infection with a ganciclovir or foscarnet susceptible HCMV strain
结局指标
主要结局
AreaUnderCurve (AUC)
时间窗: 24 hours
AUC (plasma concentration) of cidofovir during 24 hours of hemofiltration
次要结局
- maximum and minimum plasma concentration (Cmax, Cmin) of cidofovir during hemofiltration(24 hours)
- sieving coefficient of cidofovir during hemofiltration(24 hours)
- half-life (t1/2) of cidofovir during hemofiltration(24 hours)
- hemofiltration clearance (ClHF) of cidofovir during hemofiltration(24 hours)
- total body clearance (Cltot) of cidofovir during hemofiltration(24 hours)
- elimination fraction of cidofovir during hemofiltration(24 hours)
研究者
Florian Thalhammer
a.o.Univ.-Prof. Dr.
Medical University of Vienna