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临床试验/EUCTR2014-004638-24-BE
EUCTR2014-004638-24-BE进行中(未招募)1 期

Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG.

Ghent University Hospital0 个研究点目标入组 20 人开始时间: 2015年1月12日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • fUTI group:
  • -Patients aged 3 months-16 years admitted to the pediatric department of University Hospital Brussels (UZB)
  • - rectal body temperature of 38.5 °C.
  • -Significant leukocyturia or a positive urine nitrite test in a sterile urine sample
  • -ICF signed by both parents or official caregivers
  • Prophylaxis group:
  • -Patients at any age of the pediatric clinics of both University Hospital Ghent (UZG) and UZB who use cipro (at discretion of their treating physician) for preventing urinary tract infections
  • -ICF signed by both parents or official caregivers
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 20
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Impaired renal function as defined by 2x serum creatinin level for age and sex
  • Myasthenia gravis
  • Long QT-syndrome
  • Glucose 6 phosphatase deficiency (G6PD)
  • Allergy to one of the substances of cipro
  • Concomitant use of corticosteroids
  • For the prophylaxis group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements

研究者

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