Cerebral microdialysis
Conditions
Interventions
Trade Name: Doribax
Product Name: Doribax
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 148016-81-3
Other descriptive name: Doripenem
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Med. Univ. Wien, Uk für Innere Medizin I
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient age > 18 years • Application of brain microdialysis as standard care • Clinical indication for antimicrobial treatment due to bacterial infection (e.g. pneumonia, cIAI and cUTI, soft tissue infection, bacteriamia) or clinical indication for antibiotic prophylaxis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • pregnancy • no need of intensive care and bedside cerebral microdialysis as standard care • no clinical indication for antibiotic therapy or prophylaxis • impaired renal function (CrCl < 50ml/min) • Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Penetration properties of different antibiotics into the brain of neurointensive care patients with bedside cerebral microdialysis and thus to optimize antimicrobial treatment for infections of the central nervous system.;Secondary Objective: ;Primary end point(s): The concentration-vs.-time profile of doripenem in brain tissue and plasma will be measured and the following pharmacokinetic (PK) parameters will be determined: AUC0-8, AUC0-12, AUC0-24, CL, Vd, tmax, AUC 0-inf, Cmax. ;Timepoint(s) of evaluation of this end point: 3 days | — |
Countries
Austria
Contacts
Public ContactHeinz Burgmann
Med. Univ. Wien
Outcome results
None listed