Pilot Trial: Feasibility of Microdialysis for Pharmacokinetic Studies in Neonatal Patients
- Conditions
- The present pilot study intends to establish the logistics of MD measurements of antibiotics in subcutaneous tissue of neonatal intensive care patients. Antibiotic serum levels will be measured in parallel at certain time points to correlate these with MD measurements. The findings of the present study will help to establish and validate MD as a method for PK studies in paediatric patients.
- Registration Number
- EUCTR2010-020939-40-AT
- Lead Sponsor
- Medizinische Universität Wien,Univ.Klinik f.Kinder-u.Jugendheilkunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method