Amikacin Penetration Into the Cerebrospinal Fluid
Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gram Negative Meningitis; Post Traumatic Bacterial Meningitis
Intervention: Systemic and Intra-Thecal Amikacin Therapy (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s):
Yedidiah Bentur, MD, Principal Investigator, Affiliation: Rambam Health Care Campus
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.
Clinical Details
Official title: Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-Negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bactericidal effect on the causative bacteriaBlood and CSF AUC/MIC relationship
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Rambam Health Care Campus, Haifa 31096, Israel
Additional Information
Starting date: September 2006
Last updated: October 22, 2007
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