Amikacin Penetration Into the Cerebrospinal Fluid

Gram Negative Meningitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00362245
• Other study ID #: 07/2006_CTIL
• Status: Withdrawn
• Phase: Phase 4
• First received: August 8, 2006
• Last updated: November 1, 2015
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: November 2015
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gram Negative Meningitis
• Meningitis
• Meningitis, Bacterial
• Post Traumatic Bacterial Meningitis

Intervention

Drug:
• Systemic and Intra-Thecal Amikacin Therapy

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bactericidal effect on the causative bacteria
Primary	Blood and CSF AUC/MIC relationship