EUCTR2014-004638-24-BE进行中(未招募)1 期
Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG.
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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