EUCTR2014-004224-22-BE进行中（未招募）1 期
Temocillin pharmacokinetics in paediatrics - TEMOPEDI
niversité catholique de Louvain0 个研究点目标入组 45 人开始时间: 2015年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •Male or female patient requiring temocillin
- •a. for the treatment of urinary tract infections, or
- •b. for the treatment of suspicion of cholangitis associated with cirrhosis, or
- •c. as antibiotic prophylaxis following an hepatic transplant.
- •2. Requirement of hospitalization (not for social or other non-medical reasons) for at least up to 5 days
- •3. Patients aged 6 months - 3 years at the beginning of the treatment with temocillin
- •4. Parents or legal representatives able to give written informed consent in accordance with GCP and local regulatory requirements, prior to any study procedure
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •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
- •1. Ig-E mediated allergy to penicillins
- •2. Previous treatment with temocillin for the current cholangitis episode
- •3. Estimated life-expectancy of < 5 days due to major co-morbid conditions
- •4. Other serious illnesses (e.g. HIV), serious infections requiring other antibiotics, malignancy
- •5. Patients with acute or chronic renal failure (eGFR < 30ml/min)
- •6. Patients having participated in another study < 30 days before inclusion in the present study
研究者
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