Gram Negative Meningitis, Post Traumatic Bacterial Meningitis
Conditions
Keywords
Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
Brief 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.
Detailed description
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.
Interventions
DRUGSystemic and Intra-Thecal Amikacin Therapy
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bactericidal effect on the causative bacteria | — |
| Blood and CSF AUC/MIC relationship | — |
Countries
Israel
Outcome results
None listed