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

Completed · Phase 4

Conditions studied: Intraventricular Hemorrhage, Subarachnoid Hemorrhage

In brief

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

Key facts

Study ID

NCT00197392

Run by

Codman & Shurtleff

People needed

434

Starts

2004-11-01

Expected to finish

2010-01-01

Last updated by the study team

2013-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Syracuse, New York, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Sherbrooke, Quebec, Canada
• Tiantan Hospital — Beijing, China
• Xuan Wu Hospital — Beijing, China
• Study site — Angers, France
• Study site — Lille, France
• Study site — Paris, France
• Prince of Wales Hospital — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• Study site — Oslo, Norway
• National Neuroscience Institute — Singapore, Singapore
• Singapore General Hospital — Singapore, Singapore
• Study site — Bristol, United Kingdom
• Study site — Leeds, United Kingdom
• Study site — Salford, United Kingdom

Full record on ClinicalTrials.gov

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