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Amikacin Penetration Into the Cerebrospinal Fluid

Information source: Rambam Health Care Campus
Information obtained from ClinicalTrials.gov on June 20, 2008
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Status: Withdrawn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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Primary outcome:

Bactericidal effect on the causative bacteria

Blood 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

Page last updated: June 20, 2008

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