NCT00286104

Brief Summary

External ventricular catheters are used for intracranial pressure monitoring and temporary cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent literature. Previous prospective studies in the investigators' unit have shown that the use of dual antibiotics prophylaxis in patients with external ventricular drain was associated with decreased incidence of CSF infection but was complicated with opportunistic extracranial infections. The current practice is to cover with prophylactic dual antibiotics unless guided by microbiology results for all patients with external ventricular drain. In recent years, cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been available. Experimental studies have shown that they provide protection against staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56 days. Theoretically, they provide the antibiotic prophylaxis locally without the associated complications of systemic antibiotics. It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

July 1, 2009

Enrollment Period

4.7 years

First QC Date

February 1, 2006

Last Update Submit

December 21, 2009

Conditions

HydrocephalusIntracranial Hypertension

Keywords

VentriculitisExternal ventricular catheterAntibiotic-impregnated

Outcome Measures

Primary Outcomes (2)

  • Cerebrospinal fluid infection rate

    First 30 days

  • Extracranial infection rate

    First 30 days

Secondary Outcomes (2)

  • Mortality rate

    At discharge and six months

  • Glasgow Outcome Scale Extended

    At discharge and at six months

Study Arms (2)

1

ACTIVE COMPARATOR

Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated)

Device: Antibiotics-impregnated ventricular catheter (Bactiseal®)

2

PLACEBO COMPARATOR

Plain ventricular catheter

Device: Plain ventricular catheter (Codman EDS II/III)

Interventions

Antibiotics-impregnated ventricular catheter (Bactiseal®)DEVICE

Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)

Also known as: Bactiseal
1
Plain ventricular catheter (Codman EDS II/III)DEVICE

Plain ventricular catheter

Also known as: Codman EDS II/III
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with external ventricular drain inserted
  • Patients with external ventricular drain in-situ planned for at least 5 days

You may not qualify if:

  • Known CSF infection including meningitis
  • Known sepsis
  • Uncorrected coagulopathy
  • No consent available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong, 852, China

Location

Related Publications (1)

  • Wong GK, Ip M, Poon WS, Mak CW, Ng RY. Antibiotics-impregnated ventricular catheter versus systemic antibiotics for prevention of nosocomial CSF and non-CSF infections: a prospective randomised clinical trial. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1064-7. doi: 10.1136/jnnp.2009.198523. Epub 2010 May 12.

    PMID: 20466698DERIVED

MeSH Terms

Conditions

HydrocephalusIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • George KC Wong, FRCSEd(SN)

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • George KC Wong, FRCSEd(SN)

    Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

April 1, 2004

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-07

Locations

CN(1)