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Intraventricular HemorrhagePhase 4NCT00197392

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

A Phase 4 study testing Bactiseal TM EVD and Standard EVD Catheter in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Codman & Shurtleff at 20 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bactiseal TM EVD and Standard EVD Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
434 participants
Where
20 sitesin 8 countries
Study dates
Nov 2004to Jan 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

20 sites in 8 countries.

20 sites in 8 countries

United States4 sites

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Los Angeles, California, 90033

  • Study site

    Syracuse, New York, 13213

Other trials in United States

Canada3 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Sherbrooke, Quebec

Other trials in Canada

France3 sites

  • Study site

    Angers

  • Study site

    Lille

  • Study site

    Paris, 75013

Other trials in France

United Kingdom3 sites

  • Study site

    Bristol, BS 16 1LE

  • Study site

    Leeds

  • Study site

    Salford

Other trials in United Kingdom

China2 sites

  • Tiantan Hospital

    Beijing

  • Xuan Wu Hospital

    Beijing

Other trials in China

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Singapore2 sites

  • National Neuroscience Institute

    Singapore

  • Singapore General Hospital

    Singapore

Other trials in Singapore

Norway1 site

  • Study site

    Oslo, NO-0027

Other trials in Norway

About this study

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

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

Read the 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

Being tested
Bactiseal TM EVD, Standard EVD Catheter
Keywords
Ventriculostomy, EVD
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bactiseal TM EVDDevice

    Also called EVD,Bactiseal, standard

    Standard of care implantation of external ventricular drainage catheter

  • Standard EVD CatheterDevice

    Also called EVD, ventricular catheters

    Standard of care EVD system other than Bactiseal.

Study groups in NCT00197392
Study groupRoleWhat they receive
Bactiseal TM EVDExperimentalBactiseal External Ventricular Drainage System.
Receives: Device: Bactiseal TM EVD
Standard EVD CatheterActive comparatorStandard External Ventricular Device system
Receives: Device: Standard EVD Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Duration of implanted EVD system to 2 week post implant

Secondary outcomes (12)

  1. Days to Proven Infection

    Number of days to proven infection.

    Measured: Implantation of EVD System to explant of EVD catheter, an average of ten days

  2. Class of Bacterial Agent Causing Proven Infection

    Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD

    Measured: Implantation of subject to post implant

  3. Intraluminal Colonization on Catheters

    Number of catheters with Bacterial colonization verified using fluorescence.

    Measured: Implant of subjects to post implant

  4. Device Related Adverse Events

    Number of Device Related Adverse Events

    Measured: Implanted subjects to time of explant

  5. Number of Days With Indwelling Catheter

    Days catheter was implanted in subjects

    Measured: Implant of subjects to day of explant

  6. Average Subject Age

    The average subject age

    Measured: Implant to subject

  7. Diagnosis Requiring EVD Implantation

    Primary diagnosis for implantation of EVD system

    Measured: Implantation of EVD system

  8. Non-infectious Catheter Failure in the MITT Population

    Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.

    Measured: Implant of subject to explant

  9. Time Point of Introduction of Systemic Antibiotic Therapy

    Time points of then patients received systemic antibiotic therapy

    Measured: Within 48 hours of implant of subjects to explant

  10. 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).

    Measured: Implantation of subject

  11. Length of Catheter Tunneling Into the Brain

    Length of tunneling of EVD catheter in the brain for each analysis population.

    Measured: Implant of subject

  12. Number of Catheter Insertion Attempts

    Number of insertions needed to place catheter

    Measured: Implantation of subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionDec 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
434 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00197392
Sponsor's protocol ID
BAC-IN02-002
Status last verified
Oct 2013
First submitted
13 Sep 2005
Last updated
5 Nov 2013
Data monitoring committee
No

Publications

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

  • 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. doi: 10.1136/jnnp.52.5.605.

    PubMed 2732730

  • 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. doi: 10.3171/jns.1997.87.2.0247.

    PubMed 9254088

  • 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. doi: 10.3171/jns.2003.99.5.0831.

    PubMed 14609161

  • 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. doi: 10.1097/00006123-200207000-00024.

    PubMed 12182415

  • 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. doi: 10.1016/0142-9612(94)90080-9.

    PubMed 7841297

  • 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. doi: 10.3171/jns.2003.98.4.0725.

    PubMed 12691395

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bactiseal TM EVD and Standard EVD Catheter in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Codman & Shurtleff at 20 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, France, United Kingdom, China and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Infections (time frame: Duration of implanted EVD system to 2 week post implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00197392, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.

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