NCT02598362已完成4 期
Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Serum concentrations
研究概览
简要总结
Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 3 months and 17 years of age
- •confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
- •indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.
排除标准
- •pregnancy
- •impaired renal function as defined by 2x serum creatinine 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 oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
研究组 & 干预措施
intravenous
Other
Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.
干预措施: ciprofloxacin (Drug)
oral
Other
Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.
干预措施: ciprofloxacin (Drug)
结局指标
主要结局
Serum concentrations
时间窗: 12 hours
次要结局
- Urine concentrations(12 hours)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Pharmacokinetics of ciprofloxacine in pediatric patients, a pilot study – SAFE PEDRUG.EUCTR2014-004638-24-BEGhent University Hospital20
已完成
4 期
Ciprofloxacin pharmacokinetics after IV and oral administration in cachectic elderly patients10004018PneumoniacystitisUrinary tract infectionNL-OMON50150Tergooiziekenhuizen25
已完成
不适用
To study ciprofloxacin pharmacokinetics in patients who are critically ill and undergoing continuous dialysisPatients on dialysisNutritional, Metabolic, EndocrineRenal failureISRCTN52722850Trinity College Dublin (Ireland)7
终止
不适用
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) SupportDrug EffectNCT03922451Boston Children's Hospital4
进行中（未招募）
不适用
Investigation of pharmacokinetics of Ciprofloxacin and Piperacillin/Tazobactam in Patients receiving continuous renal replacement therapyEUCTR2010-021369-66-DEDepartment of Pharmacy Universitaetsmedizin Mainz40