Back to resultsAmikacin Penetration Into the Cerebrospinal Fluid
Primary Purpose
Gram Negative Meningitis, Post Traumatic Bacterial Meningitis
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Systemic and Intra-Thecal Amikacin Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gram Negative Meningitis focused on measuring Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
Eligibility Criteria
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.
Sites / Locations
- Rambam Health Care Campus
Outcomes
Primary Outcome Measures
Bactericidal effect on the causative bacteria
Blood and CSF AUC/MIC relationship
Secondary Outcome Measures
Full Information
NCT ID
NCT00362245
First Posted
August 8, 2006
Last Updated
November 1, 2015
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00362245
Brief Title
Amikacin Penetration Into the Cerebrospinal Fluid
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
lack of participants
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram Negative Meningitis, Post Traumatic Bacterial Meningitis
Keywords
Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Systemic and Intra-Thecal Amikacin Therapy
Primary Outcome Measure Information:
Title
Bactericidal effect on the causative bacteria
Title
Blood and CSF AUC/MIC relationship
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yedidiah Bentur, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
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Amikacin Penetration Into the Cerebrospinal Fluid
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