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临床试验/NCT00458900
NCT00458900已完成2 期

Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
4
试验地点
1
主要终点
Pharmacokinetics

研究概览

简要总结

In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin.
  • IV steady state
  • Hemodynamic stability
  • Normal enteral feeding without prokinetics
  • Presence of arterial line
  • Informed consent
  • ≥ 18 jaar

排除标准

  • Dialysis patients
  • Creatinine clearance < 30 ml/min
  • Transaminase levels > 5x upper limit

研究组 & 干预措施

IV and enteral administration of moxifloxacin

Experimental

IV and enteral administration of moxifloxacin

干预措施: IV and enteral administration of moxifloxacin (Drug)

结局指标

主要结局

Pharmacokinetics

时间窗: 2 days

Pharmacokinetics will be followed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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