Concentrations of doripenem in the cerebrospinal fluid of neurointensive care patients with extraventricular drainage due to secondary obstructive hydrocephalus

Phase 1

Conditions: secondary obstructive hydrocephalus

Registration Number: EUCTR2010-020920-24-AT

Lead Sponsor: Medizinische Universität Wien, Univ.Klinik f.Innere Medizin I,Abt. f. Infektionen u.Tropenmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Male or female, aged between 18 and 85 years
•Patients with external ventriculostomy for non-inflammatory occlusive hydrocephalus (e.g. Intracerebral bleeding, subarachnoid hemorrhage or traumatic brain injury)
•Clinical indication for antimicrobial application due to bacterial infection (pneumonia, cIAI and cUTI)

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 extraventricular drainage as standard care
•no clinical indication for therapy with doripenem
•impaired renal function (CrCl < 50ml/min)
•treatment with valproic acid
•treatment with probenecid
•allergy to any ingredient in Doripenem or to any other carbapenen or beta-lactam antibiotic
•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: to test the ability of doripenem to penetrate into the CSF of neurointensive care patients with extraventricular drainage due to secondary obstructive hydrocephalus;Secondary Objective: -;Primary end point(s): The concentration-vs.-time profile of doripenem in CSF and plasma will be measured and the following pharmacokinetic (PK) parameters will be determined: AUC0-8, AUC0-24, CL, Vd, tmax, AUC 0-inf, Cmax. Subsequently, PK will be related to minimal inhibitory concentrations (PD) of relevant pathogens causing post-neurosurgical nosocomial infections, and PK/PD calculations will be performed.

Secondary Outcome Measures