Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System - Full Text View

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
Ventricular Hemorrhage Subarachnoid Hemorrhage	Device: Bactiseal TM EVD	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:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

The rate of infection for the Codman B-EVD in comparison to the conventional EVD catheter (ventriculostomy-related infections) throughout the duration of the implanted EVD systems and for a 2-week period post-explant. [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The time to infection [ Time Frame: End of trial ] [ Designated as safety issue: No ]
The class of bacteria [ Time Frame: End of trial ] [ Designated as safety issue: No ]
The rate and extent of intraluminal bacterial colonization in EVD catheter systems [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Device related adverse events [ Time Frame: On-going ] [ Designated as safety issue: Yes ]
Influence of number of days with indwelling catheter [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Subject age and diagnosis (reasons for catheter placement) on infection rates [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Procedural differences and techniques [ Time Frame: End of trial ] [ Designated as safety issue: No ]
The influence of concurrent systemic antibiotics on infection rates [ Time Frame: End of trial ] [ Designated as safety issue: No ]
Health economic inferences. [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Enrollment:	515
Study Start Date:	November 2004
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Standard of care implantation of external ventricular drainage catheter

Other Name: EVD,Bactiseal, standard

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

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
Prince of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Norway

Oslo, Norway, NO-0027
Singapore
Singapore General Hospital
Singapore, Singapore
National Neuroscience Institute
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:

Bayston R. Hydrocephalus Shunt Infections. Chapman and Hall Medical, London, 1989, p. 23.

Bayston R, Grove N, Siegel J, Lawellin D, Barsham S. Prevention of hydrocephalus shunt catheter colonisation in vitro by impregnation with antimicrobials. J Neurol Neurosurg Psychiatry. 1989 May;52(5):605-9.

Bayston R, Lambert E. Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg. 1997 Aug;87(2):247-51.

Govender ST, Nathoo N, van Dellen JR. Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg. 2003 Nov;99(5):831-9.

Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. Review.

Zabramski JM, Whiting D, Darouiche RO, Horner TG, Olson J, Robertson C, Hamilton AJ. Efficacy of antimicrobial-impregnated external ventricular drain catheters: a prospective, randomized, controlled trial. J Neurosurg. 2003 Apr;98(4):725-30.

Responsible Party:	J. Thomas Megerian, Director, Clinical Research, Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00197392 History of Changes
Other Study ID Numbers:	BAC-IN02-002
Study First Received:	September 13, 2005
Last Updated:	February 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:

Ventriculostomy
EVD

Additional relevant MeSH terms:

Hemorrhage
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013