Pilot Trial: Feasibility of Microdialysis for Pharmacokinetic Studies in Neonatal Patients

Medizinische Universität Wien,Univ.Klinik f.Kinder-u.Jugendheilkunde0 个研究点开始时间: 2010年7月15日最近更新: 2016年4月11日

试验速览

暂无简介。

•Male or female newborn babies born after 28 weeks post-gestational age (i.e. 28+0 weeks post-gestational age or older)
•Clinical diagnosis of infection, requiring antibiotic therapy
•Prescription of ampicillin, gentamicin or vancomycin for therapeutic reasons.
•Signed informed consent by at least one parent or legal representative
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•HIV, Hepatitis B or C positive.
•Major congenital malformations
•Allergy or hypersensitivity against study drug.
•Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L
•Severe thrombocytopenia <50.000/µl
•Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator

发起方

Medizinische Universität Wien,Univ.Klinik f.Kinder-u.Jugendheilkunde