Amikacin Penetration Into the Cerebrospinal Fluid | NCT00362245

Studies
Amikacin Penetration Into the Cerebrospinal Fluid

NCT00362245

Sponsor

Rambam Health Care Campus

Status

Withdrawn

Last Update Posted

Nov 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Gram Negative Meningitis
Post Traumatic Bacterial Meningitis

Interventions

Systemic and Intra-Thecal Amikacin Therapy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of participants

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Aug 8, 2006

First Submission Date that Met QC Criteria

Aug 8, 2006

First Posted Date

Aug 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Description Module

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 Amikacin administered intrathecally will enable to propose rational treatment of these patients.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Systemic and Intra-Thecal Amikacin Therapy	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bactericidal effect on the causative bacteria
Blood and CSF AUC/MIC relationship

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yedidiah Bentur, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa		31096	Israel