Overview

Amikacin Penetration Into the Cerebrospinal Fluid

Status:
Withdrawn
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rambam Health Care Campus
Treatments:
Amikacin
Criteria
Inclusion Criteria:

1. Culture proved bacterial meningitis where the prescribed therapy includes the use of
systemic and intraventricular amikacin therapy.

2. The included patient should have an intraventricular catheter placed for
intraventricular pressure measurement and admitted to an intensive care unit.

3. Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.

Exclusion Criteria:

1. Patients or legal guardians who refuse to participate in the study.

2. Known allergy to amikacin.

3. Blood creatinine concentration of 1.5 mg/dL or higher.

4. Subjects without intraventricular catheter who will need repeated lumbar punctures for
CSF amikacin determinations.

5. Patients suffering from known chronic liver disease.