Cerebral microdialysis in neurointensive care patients to determine brain penetration of antibiotics. An open label explorative study.

Conditions: Cerebral microdialysis
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2011-002758-29-AT

Lead Sponsor: Med. Univ. Wien, Uk für Innere Medizin I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures