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Amikacin Penetration Into the Cerebrospinal Fluid

This study has been withdrawn prior to enrollment.
(lack of participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362245
First Posted: August 9, 2006
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  Purpose
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.

Condition Intervention Phase
Gram Negative Meningitis Post Traumatic Bacterial Meningitis Drug: Systemic and Intra-Thecal Amikacin Therapy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Bactericidal effect on the causative bacteria
  • Blood and CSF AUC/MIC relationship

Enrollment: 0
Study Start Date: September 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362245


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Yedidiah Bentur, MD Rambam Health Care Campus
  More Information

ClinicalTrials.gov Identifier: NCT00362245     History of Changes
Other Study ID Numbers: 07/2006_CTIL
First Submitted: August 8, 2006
First Posted: August 9, 2006
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Rambam Health Care Campus:
Amikacin
Pharmacokinetics
Pharmacodynamics
Intra-Thecal injection

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Central Nervous System Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents