Amikacin Penetration Into the Cerebrospinal Fluid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gram Negative Meningitis Post Traumatic Bacterial Meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Systemic and Intra-Thecal Amikacin Therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No