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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020920-24-AT

Enrollment

Unknown

Registered

2010-10-08

Start date

2010-10-20

Completion date

Unknown

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

secondary obstructive hydrocephalus

Interventions

Trade Name: DORIBAX 500 mg - Pulver zur Herstellung einer Infusionsloesung Product Name: DORIBAX 500 mg - Pulver zur Herstellung einer Infusionsloesung Pharmaceutical Form: Powder and solvent for solu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026