Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00197392
First received: September 13, 2005
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates of ventriculostomy-related infection between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized open label study


Condition Intervention Phase
Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Device: Bactiseal TM EVD
Device: Standard EVD Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • Number of Infections [ Time Frame: Duration of implanted EVD system to 2 week post implant ] [ Designated as safety issue: No ]
    The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).


Secondary Outcome Measures:
  • Days to Proven Infection [ Time Frame: Implantation of EVD System to explant of EVD catheter, an average of ten days ] [ Designated as safety issue: No ]
    Number of days to proven infection.

  • Class of Bacterial Agent Causing Proven Infection [ Time Frame: Implantation of subject to post implant ] [ Designated as safety issue: No ]
    Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD

  • Intraluminal Colonization on Catheters [ Time Frame: Implant of subjects to post implant ] [ Designated as safety issue: No ]
    Number of catheters with Bacterial colonization verified using fluorescence.

  • Device Related Adverse Events [ Time Frame: Implanted subjects to time of explant ] [ Designated as safety issue: Yes ]
    Number of Device Related Adverse Events

  • Number of Days With Indwelling Catheter [ Time Frame: Implant of subjects to day of explant ] [ Designated as safety issue: No ]
    Days catheter was implanted in subjects

  • Average Subject Age [ Time Frame: Implant to subject ] [ Designated as safety issue: No ]
    The average subject age

  • Diagnosis Requiring EVD Implantation [ Time Frame: Implantation of EVD system ] [ Designated as safety issue: No ]
    Primary diagnosis for implantation of EVD system

  • Non-infectious Catheter Failure in the MITT Population [ Time Frame: Implant of subject to explant ] [ Designated as safety issue: No ]
    Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.

  • Time Point of Introduction of Systemic Antibiotic Therapy [ Time Frame: Within 48 hours of implant of subjects to explant ] [ Designated as safety issue: No ]
    Time points of then patients received systemic antibiotic therapy

  • Hospital Locations for EVD Catheter Placement [ Time Frame: Implantation of subject ] [ Designated as safety issue: No ]
    Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).

  • Length of Catheter Tunneling Into the Brain [ Time Frame: Implant of subject ] [ Designated as safety issue: No ]
    Length of tunneling of EVD catheter in the brain for each analysis population.

  • Number of Catheter Insertion Attempts [ Time Frame: Implantation of subject ] [ Designated as safety issue: No ]
    Number of insertions needed to place catheter


Enrollment: 434
Study Start Date: November 2004
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bactiseal TM EVD
Bactiseal External Ventricular Drainage System.
Device: Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter
Other Name: EVD,Bactiseal, standard
Active Comparator: Standard EVD Catheter
Standard External Ventricular Device system
Device: Standard EVD Catheter
Standard of care EVD system other than Bactiseal.
Other Name: EVD, ventricular catheters

Detailed Description:

External ventricular drainage catheters are widely used in the management of Subjects with elevated intra-cranial pressure (ICP) secondary to acute hydrocephalus due to sub-arachnoid hemorrhage, intra-cerebral hemorrhage, intra-ventricular hemorrhage and other causes that obstruct the cerebrospinal fluid (CSF) circulation. However, this mode of treatment could be compromised by the increased risk of catheter related CSF infection.

B-EVD is manufactured using a patented process to impregnate silicone catheters with two antibiotics, rifampin and clindamycin. These antibiotics are impregnated throughout the silicone matrix. After implantation, slow release of both antibiotics at the extra- and intra-luminal catheter surfaces minimizes the likelihood of bacterial colonization. The B-EVD Catheter System has, to date, been well accepted by domestic and European customers. Currently there exists sound scientific rationale and promising bench-top in vitro data to anticipate low levels of ventriculostomy-related infection in Subjects using this system. Published BACTISEAL shunt data and direct feedback from U.S. market experience also support this notion. There are no published clinical studies reporting infection rates with the use of the B-EVD System, making all statements regarding its propensity to minimize clinical risk for catheter-related infection mere speculation and anecdotal. Therefore, Codman proposes to undertake a controlled clinical evaluation of this product to demonstrate its influence on EVD catheter-related infections, using a conventional EVD catheter as a standard of reference.

Immediately following successful screening, the Subject will be randomized to test or control group and will have the appropriate EVD system implanted. The Treatment Phase will cover the duration of the implanted EVD system. Subjects will be monitored for 2 weeks post-explant.

This study is expected to enroll 600 evaluable implanted Subjects at up to 15 Investigational Sites in US, Europe and Asia-Pacific

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The Subject is 18 years or older.
  • The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.
  • The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.

Exclusion Criteria:

  • Within the preceding 30 days, the Subject has enrolled or participated in another trial utilizing an anti-microbial drug or medical device implanted in or directly influencing the CNS and/or spinal cord.
  • The Subject is pregnant or lactating.
  • The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.
  • The Subject has a positive CSF culture prior to EVD implant.
  • The Subject is immunocompromised.
  • The Subject requires more than one ventricular catheter concurrently.
  • The Subject has had an EVD catheter within the previous 30 days.
  • The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.
  • The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.
  • The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.
  • The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.
  • The Subject is a prisoner.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197392

Locations
United States, California
Los Angeles, California, United States, 90033
United States, Florida
Gainesville, Florida, United States, 32610
United States, New York
Syracuse, New York, United States, 13213
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, Quebec
Sherbrooke, Quebec, Canada
China
Xuan Wu Hospital
Beijing, China
Tiantan Hospital
Beijing, China
France
Angers, France
Lille, France
Paris, France, 75013
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Norway
Oslo, Norway, NO-0027
Singapore
National Neuroscience Institute
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
United Kingdom
Bristol, United Kingdom, BS 16 1LE
Leeds, United Kingdom
Salford, United Kingdom
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Study Director: J. Thomas Megerian, MD, PhD Unaffilliated
  More Information

Publications:
Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00197392     History of Changes
Other Study ID Numbers: BAC-IN02-002
Study First Received: September 13, 2005
Results First Received: March 2, 2012
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:
Ventriculostomy
EVD

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014