Status:

WITHDRAWN

Amikacin Penetration Into the Cerebrospinal Fluid

Lead Sponsor:

Rambam Health Care Campus

Conditions:

Gram Negative Meningitis

Post Traumatic Bacterial Meningitis

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

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 Amik...

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 Amik...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00362245

Start Date

September 1 2006

End Date

November 1 2008

Last Update

November 3 2015

Active Locations (1)

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Rambam Health Care Campus

Haifa, Israel, 31096