Distribution of antibiotic drugs in brain fluid of childre

Phase 1

• Conditions: We will obtain pharmacokinetic data of cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam and cefazolin in cerebrospinal fluid and plasma of children with external ventricular drain. The children will be receiving the drug for treatment of infection at the discretion of their treating physicians on the neonatal intensive care unit.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002278-33-AT
• Lead Sponsor: Department of Clinical Pharmacology/Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-28
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified