HydrocephalusPhase 3NCT00286104
Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter
A Phase 3 study testing Antibiotics-impregnated ventricular catheter (Bactiseal®) and Plain ventricular catheter (Codman EDS II/III) in people with Hydrocephalus and Intracranial Hypertension, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
External ventricular catheters are used for intracranial pressure monitoring and temporary cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent literature. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hydrocephalus, Intracranial Hypertension
- What is being tested?
- Antibiotics-impregnated ventricular catheter (Bactiseal®) and Plain ventricular catheter (Codman EDS II/III)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- Apr 2004to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with external ventricular drain inserted
- Patients with external ventricular drain in-situ planned for at least 5 days
Who cannot join
- Known CSF infection including meningitis
- Known sepsis
- Uncorrected coagulopathy
- No consent available
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Neurosurgery, Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong, 852
About this study
Official title: The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter: A Prospective Randomized Study
External ventricular catheters are used for intracranial pressure monitoring and temporary cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent literature. Previous prospective studies in the investigators' unit have shown that the use of dual antibiotics prophylaxis in patients with external ventricular drain was associated with decreased incidence of CSF infection but was complicated with opportunistic extracranial infections. The current practice is to cover with prophylactic dual antibiotics unless guided by microbiology results for all patients with external ventricular drain. In recent years, cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been available. Experimental studies have shown that they provide protection against staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56 days. Theoretically, they provide the antibiotic prophylaxis locally without the associated complications of systemic antibiotics.
It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Read the detailed description
Objective:
- To assess the cranial and extracranial infection rate of systemic antibiotic prophylaxis versus antibiotics-impregnated catheter.
- To assess the patients' outcome and carry out cost analysis for systemic antibiotic prophylaxis versus antibiotics-impregnated catheter.
Design: Prospective randomized controlled trial
Hypothesis: The use of antibiotics-impregnated catheter instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infection and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Method: After ventricular catheter insertion, patients will be randomized into one of the two groups:
- Periprocedural antibiotics: Only ie Unasyn and Rocephin and insertion of the antibiotics-impregnated ventricular catheter.
- Periprocedural antibiotics and prophylactic dual antibiotics ie Unasyn and Rocephin and insertion of ventricular catheter without impregnation of antibiotics.
Primary outcome variable: Cerebrospinal fluid infection and extracranial infection.
Sample size: We aim to recruit a total of 180 patients with 90 patients in each arm and expect to complete patient recruitment in 2-3 years. The calculation is based to detect a difference of nosocomial infection rate between 20% and 40%, with 5% level of significance and 80% power.
Projected results and significance:
The project has a good chance to be the first clinical study to the outcome and cost impacts of antibiotic-impregnated ventricular catheter.
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Being tested
- Antibiotics-impregnated ventricular catheter (Bactiseal®), Plain ventricular catheter (Codman EDS II/III)
- Keywords
- Ventriculitis, External ventricular catheter, Antibiotic-impregnated
- Medical subject headings
- Hydrocephalus, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics-impregnated ventricular catheter (Bactiseal®)Device
Also called Bactiseal
Antibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated)
Plain ventricular catheter (Codman EDS II/III)Device
Also called Codman EDS II/III
Plain ventricular catheter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated) Receives: Device: Antibiotics-impregnated ventricular catheter (Bactiseal®) |
| 2 | Placebo comparator | Plain ventricular catheter Receives: Device: Plain ventricular catheter (Codman EDS II/III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid infection rate
Measured: First 30 days
Extracranial infection rate
Measured: First 30 days
Secondary outcomes (2)
Mortality rate
Measured: At discharge and six months
Glasgow Outcome Scale Extended
Measured: At discharge and at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startApr 2004
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- George KC Wong, FRCSEd(SN), Principal investigator, Chinese University of Hong KongGeorge KC Wong, FRCSEd(SN), Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286104
- Sponsor's protocol ID
- CREC-PWS-002
- Status last verified
- Jul 2009
- First submitted
- 1 Feb 2006
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong GK, Ip M, Poon WS, Mak CW, Ng RY. Antibiotics-impregnated ventricular catheter versus systemic antibiotics for prevention of nosocomial CSF and non-CSF infections: a prospective randomised clinical trial. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1064-7. doi: 10.1136/jnnp.2009.198523. Epub 2010 May 12.
PubMed 20466698
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ventricular Catheter Impregnated With Antimicrobial Agents on Infection in Patients With Ventricular Catheter: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00286104
- Acronym / sponsor ID
- CREC-PWS-002
- Conditions
- Hydrocephalus, Intracranial Hypertension
- Keywords
- Ventriculitis, External ventricular catheter, Antibiotic-impregnated
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
External ventricular catheters are used for intracranial pressure monitoring and temporary cerebrospinal fluid (CSF) drainage in neurosurgery. The incidence of ventriculostomy-related cerebrospinal fluid infections had been quoted as between 2.2% to 10.4% in the more recent literature. Previous prospective studies in the investigators' unit have shown that the use of dual antibiotics prophylaxis in patients with external ventricular drain was associated with decreased incidence of CSF infection but was complicated with opportunistic extracranial infections. The current practice is to cover with prophylactic dual antibiotics unless guided by microbiology results for all patients with external ventricular drain. In recent years, cerebrospinal fluid shunt catheters impregnated with antimicrobial agents have been available. Experimental studies have shown that they provide protection against staphylococcal aureus and coagulase-negative staphylococci strains for between 42 days and 56 days. Theoretically, they provide the antibiotic prophylaxis locally without the associated complications of systemic antibiotics.
It is hypothesized that the use of antibiotic-impregnated catheters instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infections and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Detailed description
Objective:
- To assess the cranial and extracranial infection rate of systemic antibiotic prophylaxis versus antibiotics-impregnated catheter.
- To assess the patients' outcome and carry out cost analysis for systemic antibiotic prophylaxis versus antibiotics-impregnated catheter.
Design: Prospective randomized controlled trial
Hypothesis: The use of antibiotics-impregnated catheter instead of systemic antibiotic prophylaxis will not increase the rate of cerebrospinal fluid infection, will decrease the rate of opportunistic/nosocomial infection and improves the overall outcome in these patients; that would convert into a reduction in treatment cost of these patients.
Method: After ventricular catheter insertion, patients will be randomized into one of the two groups:
- Periprocedural antibiotics: Only ie Unasyn and Rocephin and insertion of the antibiotics-impregnated ventricular catheter.
- Periprocedural antibiotics and prophylactic dual antibiotics ie Unasyn and Rocephin and insertion of ventricular catheter without impregnation of antibiotics.
Primary outcome variable: Cerebrospinal fluid infection and extracranial infection.
Sample size: We aim to recruit a total of 180 patients with 90 patients in each arm and expect to complete patient recruitment in 2-3 years. The calculation is based to detect a difference of nosocomial infection rate between 20% and 40%, with 5% level of significance and 80% power.
Projected results and significance:
The project has a good chance to be the first clinical study to the outcome and cost impacts of antibiotic-impregnated ventricular catheter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Antibiotics-impregnated ventricular catheter (Bactiseal®)Bactiseal ventricular catheter (Rifampicin- and Clindamycin-impregnated) |
| 2 | Placebo comparator | Device: Plain ventricular catheter (Codman EDS II/III)Plain ventricular catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with external ventricular drain inserted
- Patients with external ventricular drain in-situ planned for at least 5 days
Key exclusion criteria (4 listed)
- Known CSF infection including meningitis
- Known sepsis
- Uncorrected coagulopathy
- No consent available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics-impregnated ventricular catheter (Bactiseal®)Also: BactisealAntibiotics-impregnated ventricular catheter (Rifampicin- and Clindamycin-impregnated) | Device | 1 |
| Plain ventricular catheter (Codman EDS II/III)Also: Codman EDS II/IIIPlain ventricular catheter | Device | 2 |
Primary outcome
Cerebrospinal fluid infection rate
Time frame: First 30 days
Extracranial infection rate
Time frame: First 30 days
2 secondary outcomes
Mortality rate
Time frame: At discharge and six months
Glasgow Outcome Scale Extended
Time frame: At discharge and at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Derived from this study: PubMed 20466698Wong GK, Ip M, Poon WS, Mak CW, Ng RY. Antibiotics-impregnated ventricular catheter versus systemic antibiotics for prevention of nosocomial CSF and non-CSF infections: a prospective randomised clinical trial. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1064-7. doi: 10.1136/jnnp.2009.198523. Epub 2010 May 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George KC Wong, FRCSEd(SN) principal investigator
Chinese University of Hong Kong
George KC Wong, FRCSEd(SN) study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotics-impregnated ventricular catheter (Bactiseal®) and Plain ventricular catheter (Codman EDS II/III) in people with Hydrocephalus and Intracranial Hypertension, run by Chinese University of Hong Kong at 1 site in China.
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 2 inclusion and 4 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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebrospinal fluid infection rate (time frame: First 30 days). The study lists 2 primary outcomes in all. 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 NCT00286104, which also lists 1 linked publication.
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 23 Dec 2009.