Amikacin Penetration Into the Cerebrospinal Fluid

Rambam Health Care Campus

Status and phase: Withdrawn; Phase 4

Conditions: Gram Negative Meningitis; Post Traumatic Bacterial Meningitis

Treatments: Drug: Systemic and Intra-Thecal Amikacin Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00362245

07/2006_CTIL

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)