EUCTR2018-002278-33-ATActive, not recruitingPhase 1
Pharmacokinetics of antibiotics in cerebrospinal fluid of children with external ventricular drain - PK_AB_NIC
Department of Clinical Pharmacology/Medical University of Vienna0 sites48 target enrollmentStarted: August 28, 2018Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Female or male, aged between 3 days and 3 months (study groups with cefuroxime, vancomycin, ampicillin, piperacillin/tazobactam and cefazolin)
- •Female or male, aged between 7 days and 3 months (study groups with gentamicin and linezolid)
- •External ventricular drain in place
- •Hospitalisation on an intensive care or intermediate care unit
- •Clinical diagnosis of infection, requiring antibiotic therapy or antibiotic therapy as infection prophylaxis
- •Current or planned therapy with cefuroxime, gentamicin, vancomycin, ampicillin, linezolid, piperacillin/tazobactam or cefazolin as treatment or prophylaxis of a bacterial infection (any localisation).
- •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: 56
- •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
Exclusion Criteria
- •Allergy or hypersensitivity against study drug
- •Severe renal impairment, defined by a serum creatinine level of more than 200% of age-specific reference values, or urinary output <0,5ml/kg/h for >12 hours
- •Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator
Investigators
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