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

Subarachnoid Hemorrhage Clinical Trial

Official title:

Establishment of Baseline and Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197392
• Other study ID #: BAC-IN02-002
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: October 11, 2013
• Start date: November 2004
• Est. completion date: January 2010

Study information

• Verified date: October 2013
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Bactiseal TM EVD
Standard of care implantation of external ventricular drainage catheter
• Standard EVD Catheter
Standard of care EVD system other than Bactiseal.

Locations

Country	Name	City	State
China	Tiantan Hospital	Beijing
China	Xuan Wu Hospital	Beijing
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Singapore	National Neuroscience Institute	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Countries where clinical trial is conducted

United States,  Canada,  China,  France,  Hong Kong,  Norway,  Singapore,  United Kingdom, 

References & Publications (8)

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. — View Citation

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. — View Citation

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

Codman in house testing reports, TR2213 and PVER99-133 Addendum

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. — View Citation

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. — View Citation

Schierholz J, Jansen B, Jaenicke L, Pulverer G. In-vitro efficacy of an antibiotic releasing silicone ventricle catheter to prevent shunt infection. Biomaterials. 1994 Oct;15(12):996-1000. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Infections	The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).	Duration of implanted EVD system to 2 week post implant	No
Secondary	Days to Proven Infection	Number of days to proven infection.	Implantation of EVD System to explant of EVD catheter, an average of ten days	No
Secondary	Class of Bacterial Agent Causing Proven Infection	Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD	Implantation of subject to post implant	No
Secondary	Intraluminal Colonization on Catheters	Number of catheters with Bacterial colonization verified using fluorescence.	Implant of subjects to post implant	No
Secondary	Device Related Adverse Events	Number of Device Related Adverse Events	Implanted subjects to time of explant	Yes
Secondary	Number of Days With Indwelling Catheter	Days catheter was implanted in subjects	Implant of subjects to day of explant	No
Secondary	Average Subject Age	The average subject age	Implant to subject	No
Secondary	Diagnosis Requiring EVD Implantation	Primary diagnosis for implantation of EVD system	Implantation of EVD system	No
Secondary	Non-infectious Catheter Failure in the MITT Population	Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.	Implant of subject to explant	No
Secondary	Time Point of Introduction of Systemic Antibiotic Therapy	Time points of then patients received systemic antibiotic therapy	Within 48 hours of implant of subjects to explant	No
Secondary	Hospital Locations for EVD Catheter Placement	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).	Implantation of subject	No
Secondary	Length of Catheter Tunneling Into the Brain	Length of tunneling of EVD catheter in the brain for each analysis population.	Implant of subject	No
Secondary	Number of Catheter Insertion Attempts	Number of insertions needed to place catheter	Implantation of subject	No