Trial Outcomes & Findings for Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System (NCT NCT00197392)
NCT ID: NCT00197392
Last Updated: 2013-11-05
Results Overview
The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
434 participants
Primary outcome timeframe
Duration of implanted EVD system to 2 week post implant
Results posted on
2013-11-05
Participant Flow
Participant milestones
| Measure |
Bactiseal EVD
Subjects treated with Bactiseal EVD catheter
|
Conventional EVD Catheter
Subjects treated with Standard EVD catheter
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
220
|
|
Overall Study
Safety Population
|
214
|
220
|
|
Overall Study
Modified Intent to Treat
|
209
|
210
|
|
Overall Study
Evaluable
|
176
|
181
|
|
Overall Study
Per Protocol
|
126
|
134
|
|
Overall Study
COMPLETED
|
126
|
134
|
|
Overall Study
NOT COMPLETED
|
88
|
86
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Baseline characteristics by cohort
| Measure |
Bactiseal EVD
n=214 Participants
|
Standard EVD
n=220 Participants
|
Total
n=434 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.7 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
53.05 years
STANDARD_DEVIATION 15.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
42 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
27 participants
n=5 Participants
|
33 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
China
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
38 participants
n=5 Participants
|
45 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of implanted EVD system to 2 week post implantThe number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=209 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=210 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Number of Infections
Modified intent to Treat
|
4 Infections
|
5 Infections
|
|
Number of Infections
Evaluable
|
4 Infections
|
5 Infections
|
|
Number of Infections
Per Protocol
|
1 Infections
|
3 Infections
|
SECONDARY outcome
Timeframe: Implantation of EVD System to explant of EVD catheter, an average of ten daysNumber of days to proven infection.
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=214 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=220 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Days to Proven Infection
Modified Intent to Treat
|
9.5 Days
Standard Deviation 3.3
|
10 Days
Standard Deviation 3.0
|
|
Days to Proven Infection
Evaluable
|
9.5 Days
Standard Deviation 3.3
|
10 Days
Standard Deviation 3.0
|
|
Days to Proven Infection
Per protocol
|
14 Days
Standard Deviation 1
|
10 Days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Implantation of subject to post implantPopulation: All subjects included in the MITT, Evaluable and Per-Protocol population.
Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=22 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=22 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Class of Bacterial Agent Causing Proven Infection
Bacilli
|
11 participants
|
0 participants
|
|
Class of Bacterial Agent Causing Proven Infection
Gamma Proteobacteria
|
0 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Implant of subjects to post implantNumber of catheters with Bacterial colonization verified using fluorescence.
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=209 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=210 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Intraluminal Colonization on Catheters
|
0 catheters
|
3 catheters
|
SECONDARY outcome
Timeframe: Implanted subjects to time of explantPopulation: There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.
Number of Device Related Adverse Events
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=214 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=220 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Device Related Adverse Events
Modifeid Intent to Treat
|
0 events
|
1 events
|
|
Device Related Adverse Events
Evaluable
|
1 events
|
4 events
|
|
Device Related Adverse Events
Per protocol
|
0 events
|
0 events
|
|
Device Related Adverse Events
Safety
|
0 events
|
2 events
|
SECONDARY outcome
Timeframe: Implant of subjects to day of explantDays catheter was implanted in subjects
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=192 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=199 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Number of Days With Indwelling Catheter
Modified Intent to Treat
|
8.7 Days
Standard Deviation 5.7
|
8.9 Days
Standard Deviation 6.0
|
|
Number of Days With Indwelling Catheter
Evaluable
|
9.3 Days
Standard Deviation 5.5
|
9.7 Days
Standard Deviation 5.8
|
|
Number of Days With Indwelling Catheter
Per Protocol
|
9.8 Days
Standard Deviation 5.7
|
10.4 Days
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Implant to subjectThe average subject age
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=209 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=210 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Average Subject Age
Modified Intent to Treat
|
51.9 Years
Standard Deviation 16.1
|
54.4 Years
Standard Deviation 14.7
|
|
Average Subject Age
Evaluable
|
51.9 Years
Standard Deviation 16.1
|
54.5 Years
Standard Deviation 14.6
|
|
Average Subject Age
Per protocol
|
49.4 Years
Standard Deviation 15.8
|
54.2 Years
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: Implantation of EVD systemPopulation: Analysis consisted of combining both Arm/Group (Bactiseal and Standard)
Primary diagnosis for implantation of EVD system
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=419 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Diagnosis Requiring EVD Implantation
Hydrocephalus - Per Protocol
|
50 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Edema - Modified Intent to Treat
|
20 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Edema - Evaluable
|
17 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Edema - Per Protocol
|
13 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Hemorrhage - Modified Intent to Treat
|
335 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Hemorrhage - Evaluable
|
282 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Hemorrhage - Per protocol
|
197 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Hydrocephalus - Modified Intent to Treat
|
64 Participants
|
—
|
|
Diagnosis Requiring EVD Implantation
Hydrocephalus - Evaluable
|
58 Participants
|
—
|
SECONDARY outcome
Timeframe: Implant of subject to explantReasons for non-infectious catheter malfunctions in the Modified intent to treat population.
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=176 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=181 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Non-infectious Catheter Failure in the MITT Population
Occlusion
|
16 Participants
|
0 Participants
|
|
Non-infectious Catheter Failure in the MITT Population
Migration
|
0 Participants
|
1 Participants
|
|
Non-infectious Catheter Failure in the MITT Population
Misplacement
|
0 Participants
|
1 Participants
|
|
Non-infectious Catheter Failure in the MITT Population
Other
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of implant of subjects to explantTime points of then patients received systemic antibiotic therapy
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=209 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=210 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Catheter Implanted (MITT)
|
167 Paticipants
|
175 Paticipants
|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Before implant, but within 48 hours (MITT)
|
146 Paticipants
|
149 Paticipants
|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Before implant, but within 48 hours (Evaluable)
|
118 Paticipants
|
124 Paticipants
|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Catheter Implanted (Evaluable)
|
150 Paticipants
|
159 Paticipants
|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Before implant, but within 48 hours (Per protocol)
|
81 Paticipants
|
90 Paticipants
|
|
Time Point of Introduction of Systemic Antibiotic Therapy
Catheter implanted (Per Protocol)
|
108 Paticipants
|
121 Paticipants
|
SECONDARY outcome
Timeframe: Implantation of subjectNumber of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=214 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=220 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Hospital Locations for EVD Catheter Placement
ICU (MITT)
|
45 Participants
|
49 Participants
|
|
Hospital Locations for EVD Catheter Placement
OR (MITT)
|
159 Participants
|
153 Participants
|
|
Hospital Locations for EVD Catheter Placement
ICU (Evaluable)
|
37 Participants
|
41 Participants
|
|
Hospital Locations for EVD Catheter Placement
OR (Evaluable)
|
136 Participants
|
132 Participants
|
|
Hospital Locations for EVD Catheter Placement
ICU (Per Protocol)
|
22 Participants
|
25 Participants
|
|
Hospital Locations for EVD Catheter Placement
OR (Per Protocol)
|
103 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Implant of subjectLength of tunneling of EVD catheter in the brain for each analysis population.
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=202 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=205 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Length of Catheter Tunneling Into the Brain
Evaluable
|
6.2 cm
Standard Deviation 2.1
|
5.8 cm
Standard Deviation 2.1
|
|
Length of Catheter Tunneling Into the Brain
Per Protocol
|
6.0 cm
Standard Deviation 1.9
|
5.7 cm
Standard Deviation 1.8
|
|
Length of Catheter Tunneling Into the Brain
MITT
|
6.2 cm
Standard Deviation 2.2
|
5.8 cm
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Implantation of subjectNumber of insertions needed to place catheter
Outcome measures
| Measure |
Bactiseal EVD Catheter
n=206 Participants
Patients treated with Codman Bactiseal EVD Catheter
|
Standard EVD Cathter
n=208 Participants
Patients treated with Standard EVD Catheter
|
|---|---|---|
|
Number of Catheter Insertion Attempts
1 Insertion
|
177 insertions
|
178 insertions
|
|
Number of Catheter Insertion Attempts
2 insertions
|
15 insertions
|
16 insertions
|
|
Number of Catheter Insertion Attempts
3 instertions
|
9 insertions
|
11 insertions
|
|
Number of Catheter Insertion Attempts
4 instertions
|
3 insertions
|
2 insertions
|
|
Number of Catheter Insertion Attempts
5 insertions
|
2 insertions
|
1 insertions
|
Adverse Events
Standard EVD
Serious events: 16 serious events
Other events: 11 other events
Deaths: 0 deaths
Bactiseal EVD
Serious events: 14 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard EVD
n=220 participants at risk
Subjects with standard EVD
|
Bactiseal EVD
n=214 participants at risk
Subjects with Bactiseal EVD
|
|---|---|---|
|
Surgical and medical procedures
Death
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Sepsis secondary to pneumonia with complicating head injury
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Respiratory culture positive for staphylocccus
|
1.4%
3/220 • Number of events 3
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Respiratory culture positive for enterobateraerogenes
|
0.45%
1/220 • Number of events 1
|
0.93%
2/214 • Number of events 2
|
|
Nervous system disorders
Brain Death
|
0.00%
0/220
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
Respiratory culture positive for haemophilus influenzae
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Respiratory culture positive for staphylocccus aureus-oxacillan resistant (orsa)
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Throat culture positive for enterobacter aerogenes
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Nares culture positive for oxacillan resistant staphylocccus aureus
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
CSF positive for coccidiodes immitis
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Respiratory culture positive for escherichia coli
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
CSF culture positive for coagulase negative staphylococcus
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Epidural hematoma at ventriculostomy site
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
CSF infection
|
0.45%
1/220 • Number of events 1
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
CSF infection with secondary hydrocephalus
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Cardiac disorders
Right intracerebral hemorhage
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Aseptic Inflammation
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Meningitis
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Ventriculitis
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Blood Culture Positive for Coagulase Negative Staphylococcus
|
0.91%
2/220 • Number of events 2
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Vasovagal Shock at EVD Explant
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
Other adverse events
| Measure |
Standard EVD
n=220 participants at risk
Subjects with standard EVD
|
Bactiseal EVD
n=214 participants at risk
Subjects with Bactiseal EVD
|
|---|---|---|
|
Infections and infestations
Blood positive for streptococcus
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
CNS Infection
|
0.91%
2/220 • Number of events 2
|
1.9%
4/214 • Number of events 4
|
|
Infections and infestations
Coagulase negative staphylococcus in CSF
|
0.45%
1/220 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Confirmed dipthroid infection in CSF
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
CSF culture positive for coagulase negative staphylococcus
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
CSF Positive for propionibacterium
|
0.45%
1/220 • Number of events 1
|
0.93%
2/214 • Number of events 2
|
|
Infections and infestations
CSF infection - entermococcus faecacil acinetobacter banmanii
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
CSF Infection - pseudomonas
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Catheter tip - cultutre positive for coagulase negative staphylococcus
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Vascular disorders
Catheter occlusion due to hemorrhage
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Increrased intra-cranial pressure
|
0.45%
1/220 • Number of events 1
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Infection
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Meningitis
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Sputum culture positive with gram positive cocci & gram negative diplococci
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Sputum positive for gram negative & gram positive rods
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Sputum positive for staphylococcus
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Ulcer
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Surgical and medical procedures
Trubid CSF
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Infections and infestations
Urine positive for escherichia coli
|
0.00%
0/220
|
0.47%
1/214 • Number of events 1
|
|
Nervous system disorders
Vasovagal Shock
|
0.45%
1/220 • Number of events 1
|
0.00%
0/214
|
|
Infections and infestations
Sputum Positive for Staphylococcus
|
0.00%
0/220
|
0.93%
2/214 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60