BacteriaemiaPhase 4NCT00555282
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)
A Phase 4 study testing central venous catheter in people with Bacteriaemia and Catheter Related Bloodstream Infection, run by B. Braun Melsungen AG at 2 sites in Czechia.
Trial summary
The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteriaemia, Catheter Related Bloodstream Infection
- What is being tested?
- central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 2 sitesCzechia
- Study dates
- Nov 2005to Jul 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with probable ICU stay
- Patient's first or second catheter placement during actual hospital stay
- Anticipated indwelling central venous catheter period >= 3 days (jugular vein, subclavian vein)
- >= 18 years of age
- Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible
Who cannot join
- The catheter will not be placed in the femoral vein
- Inflammation of the skin at the site of puncture prior to puncture
- Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine)
- Participation in another clinical trial
- Emergency insertion of catheter in the field
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Faculty Hospital Brno
Brno, 662 43
Faculty Hospital Charles University
Prague, 100 00
About this study
Official title: Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of a Standard Central Venous Catheter (CVC) in Comparison to a Coated CVC
The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
Read the detailed description
Central venous catheters are an essential part of patient management in the ICU (Intensive Care Unit). The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. It is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. Various types of antiseptic or antimicrobial vascular catheter coatings have been developed. Studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. The "Certofix protect" was developed by B.Braun to reduce the risk of catheter related infections. It is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
- Being tested
- central venous catheter
- Keywords
- central venous catheter, cvc, coated catheter, bacteriaemia, bloodstream infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheterDevice
Also called Certofix Protect
coated central venous catheter
central venous catheterDevice
Also called Certofix Trio
standard central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | coated central venous catheter Receives: Device: central venous catheter |
| 2 | Active comparator | standard central venous catheter Receives: Device: central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter colonization
Measured: after catheter removal
Incidence of bloodstream infection
Measured: during treatment
Secondary outcomes (2)
Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers
Measured: until discharge from ICU
Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization
Measured: catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startNov 2005
- Primary completionJul 2009
- Study completionJul 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 BacteriaemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Pachl, Prof. Dr., Principal investigator, Faculty Hospital Charles University PraguePavel Sevcik, Prof. Dr., Principal investigator, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555282
- Sponsor's protocol ID
- HC-G-H-0507
- Status last verified
- Feb 2010
- First submitted
- 7 Nov 2007
- Last updated
- 5 Feb 2010
- Results posted
- No
Publications
Krikava I, Kolar M, Garajova B, Balik T, Sevcikova A, Roschke I, Sevcik P. The efficacy of a non-leaching antibacterial central venous catheter - a prospective, randomized, double-blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Jun;164(2):154-160. doi: 10.5507/bp.2019.022. Epub 2019 May 28.
PubMed 31142873
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of a Standard Central Venous Catheter (CVC) in Comparison to a Coated CVC
- ClinicalTrials.gov ID
- NCT00555282
- Acronym / sponsor ID
- HC-G-H-0507
- Keywords
- central venous catheter, cvc, coated catheter, bacteriaemia, bloodstream infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Nov 2007 (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.
The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
Detailed description
Central venous catheters are an essential part of patient management in the ICU (Intensive Care Unit). The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. It is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. Various types of antiseptic or antimicrobial vascular catheter coatings have been developed. Studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. The "Certofix protect" was developed by B.Braun to reduce the risk of catheter related infections. It is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: central venous cathetercoated central venous catheter |
| 2 | Active comparator | Device: central venous catheterstandard central venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with probable ICU stay
- Patient's first or second catheter placement during actual hospital stay
- Anticipated indwelling central venous catheter period >= 3 days (jugular vein, subclavian vein)
- >= 18 years of age
- Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible
Key exclusion criteria (5 listed)
- The catheter will not be placed in the femoral vein
- Inflammation of the skin at the site of puncture prior to puncture
- Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine)
- Participation in another clinical trial
- Emergency insertion of catheter in the field
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 |
|---|---|---|
| central venous catheterAlso: Certofix Protectcoated central venous catheter | Device | 1 |
| central venous catheterAlso: Certofix Triostandard central venous catheter | Device | 2 |
Primary outcome
Incidence of catheter colonization
Time frame: after catheter removal
Incidence of bloodstream infection
Time frame: during treatment
2 secondary outcomes
Safety of catheter: complications related to the catheter and adverse events in general, clinical therapy, TISS-Score, ICU stay, infection markers
Time frame: until discharge from ICU
Safety of catheter: central venous catheter variables, time of catheter insertion and removal, kind of colonization
Time frame: catheter removal
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 5 Feb 2010.
- Derived from this study: PubMed 31142873Krikava I, Kolar M, Garajova B, Balik T, Sevcikova A, Roschke I, Sevcik P. The efficacy of a non-leaching antibacterial central venous catheter - a prospective, randomized, double-blind study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Jun;164(2):154-160. doi: 10.5507/bp.2019.022. Epub 2019 May 28.
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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.
Jan Pachl, Prof. Dr. principal investigator
Faculty Hospital Charles University Prague
Pavel Sevcik, Prof. Dr. principal investigator
Brno University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing central venous catheter in people with Bacteriaemia and Catheter Related Bloodstream Infection, run by B. Braun Melsungen AG at 2 sites in Czechia.
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 5 inclusion and 5 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 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
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?
Incidence of catheter colonization (time frame: after catheter removal). 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 NCT00555282, 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 5 Feb 2010.