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临床试验/2024-520379-28-00
2024-520379-28-00招募中4 期

Revised dosing of Ciprofloxacin for patients with impaired renal function: a bioequivalence study

Amsterdam UMC Stichting3 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年1月24日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
58
试验地点
3
主要终点
Drug exposure in the first 24 hours of treatment (AUC0- 24)

研究概览

简要总结

To assess bioequivalence of ciprofloxacin between patients with impaired renal function (eGFR < 30 ml/min/1.73m2) receiving the revised reduced doses (test, 750 mg orally once daily or 600 mg intravenously once daily) and patients with adequate renal function receiving regular doses (reference, 500mg orally twice daily or 400 mg intravenously twice daily), by investigating whether drug exposure in the first 24 hours of treatment (AUC024) is bioequivalent between both patient groups (test/reference).

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • being treated with ciprofloxacin intravenously (iv) or orally (po) as part of standard care - age ≥ 18 years
  • being admitted to general wards of the Amsterdam UMC – location AMC or the OLVG- location Oost or Noordwest Ziekenhuisgroep
  • informed consent is obtained

排除标准

  • receiving renal replacement therapy (i.e. haemodialysis, peritoneal dialysis, continuous venovenous hemofiltration or another way of renal replacement therapy), during the first 48 hours of treatment with ciprofloxacin
  • patients with cystic fibrosis (CF)
  • informed consent is not obtained

结局指标

主要结局

Drug exposure in the first 24 hours of treatment (AUC0- 24)

Drug exposure in the first 24 hours of treatment (AUC0- 24)

次要结局

未报告次要终点

研究者

申办方类型
Patient organisation/association
责任方
Principal Investigator
主要研究者

Dr. R.M. van Hest

Scientific

Amsterdam UMC Stichting

研究点 (3)

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