Amikacin Penetration Into the Cerebrospinal Fluid
Phase 4
Withdrawn
- Conditions
- Gram Negative MeningitisPost Traumatic Bacterial Meningitis
- Registration Number
- NCT00362245
- Lead Sponsor
- Rambam Health Care Campus
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
- The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
- Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.
Exclusion Criteria
- Patients or legal guardians who refuse to participate in the study.
- Known allergy to amikacin.
- Blood creatinine concentration of 1.5 mg/dL or higher.
- Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
- Patients suffering from known chronic liver disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Blood and CSF AUC/MIC relationship Bactericidal effect on the causative bacteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rambam Health Care Campus
🇮🇱Haifa, Israel