Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous CatheterPhase 4NCT00202813
Study of the Use of Coated Venous Catheters in the Critically Ill Child
A Phase 4 study testing Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter in people with Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter, run by Corewell Health West at 1 site in United States.
Trial summary
This study should help determine to determine whether or not the use of an antibiotic coated catheter will significantly reduce the number of central line related bloodstream infections in children requiring a CVC. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter
- What is being tested?
- Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2005
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all patients ages 21 years or less admitted to the pediatric intensive care unit or general pediatric unit at DeVos Children's Hospital
- research informed consent must be signed
Who cannot join
- known allergy or sensitivity to minocycline, tetracyline, doxycycline, oxytetracycline, demeclocycline, rifampin, rifabutin
Trial locations and contacts
1 site in 1 country.
United States1 site
DeVos Children's Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: The Use of Antibiotic-coated Venous Catheters in the Critically Ill Child: Reducing the Rate of Bloodstream Related Infections
This study should help determine to determine whether or not the use of an antibiotic coated catheter will significantly reduce the number of central line related bloodstream infections in children requiring a CVC. This study may also determine if antibiotic coated catheters will be significantly less likely than non-antibiotic coated catheters to allow bacteria to live (colonize) in/on the catheter.
The use of central venous catheters (CVC) is paramount to the care of critically ill children. Thus, in the pediatric intensive care unit (PICU), these catheters are widely used in situations when more than peripheral venous access is necessary. This central access allows the delivery of fluids, e.g, blood, medications, etc. as well as serves as a means to withdraw blood. It has been estimated that more than 250,000 nosocomial bloodstream infections occur each year, with 90% of these associated with the use of CVCs. More recently, the National Nosocomial Infection Surveillance System (NNIS) reported during 1992-2001 CVC-associated bloodstream infections (BSI) in ICU settings occurred at rates of 2.9-11.3 BSI per 1,000 catheter days. The cost of treating CVC related BSI has been estimated to be in excess of $28,000 per catheter. In the adult medical literature, there is strong evidence supporting use of antiseptic or antibiotic coated catheters to reduce the cost of hospitalization for CVC related infections. Cost-benefit studies have suggested that if the baseline incidence of CVC BSI is >0.4 BSI per 1000 catheter days, $59,000 will be saved, 7 cases of BSI will be avoided, and 1 death prevented for every 300 anti-septic impregnated CVCs used.
Read the detailed description
Catheter related infections are often difficult to treat because the pathogen may form a biofilm that actually embeds itself into the catheter material. Additionally, the catheter hub and skin around this area may be colonized with bacteria. It is by this route that pathogenic organisms migrate to the external surface of the catheter, which then can progress to the intravascular tip. To decrease the risk of CVC associated infections, antibiotic coated catheters have been used. Since 1990, several types of antiseptic or antimicrobial vascular catheters have been developed. These catheters are designed to protect both the external and internal surfaces of the device from colonization of certain bacteria. Raad et al, have demonstrated in a randomized multicenter clinical trial among hospitalized adult patients that CVCs coated with minocycline and rifampin significantly reduced the risk for catheter-related colonization and bloodstream infections[8]. However, there have been no clinical trials reported in the pediatric population on this issue. This study will prospectively compare in a randomized, blinded fashion the use of two Food \& Drug Administration (FDA) approved central venous catheters - an antibiotic coated CVC to non-coated CVC at DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan. Additional major pediatric teaching hospitals may be added at a later time.
- Being tested
- Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter
- Keywords
- CVC, central venous catheter, infection, bloodstream infection, catheter infection, pediatric, children, antibiotic impregnated catheters
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous CatheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if antibiotic coated catheters reduce the risk of catheter associated BSI in children hospitalized in PICU or in inpatient pediatric ward in comparison to non-antibiotic coated catheters.
An infection free interval is defined as beginning with the insertion of the cvc (or, if applicable with the cure of a infection in a catheter that was left in place anbd concluded with one of the outcomes listed
Secondary outcomes (3)
to determine the bacterial pathogens associated with antibiotic coated CVC BSI and compare these pathogens with those normally associated with non-antibiotic coated CVC
To determine the bacterial pathogens associated with colonization of antibiotic coated catheter tips in comparison to those normally associated with non-antibiotic coated catheter tips.
To determine risk factors associated with CVC BSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous CatheterStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Responsible party
- Principal investigator, Robert Fitzgerald, Corewell Health West
- Investigators
- Robert Fitzgerald, MD, Principal investigator, Helen DeVos Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202813
- Sponsor's protocol ID
- 2003-104
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2005
- Last updated
- 8 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Antibiotic-coated Venous Catheters in the Critically Ill Child: Reducing the Rate of Bloodstream Related Infections
- ClinicalTrials.gov ID
- NCT00202813
- Acronym / sponsor ID
- 2003-104
- Keywords
- CVC, central venous catheter, infection, bloodstream infection, catheter infection, pediatric, children, antibiotic impregnated catheters
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Helen DeVos Children's Hospital
- Study start
- Jul 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 20 Sep 2005 (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.
This study should help determine to determine whether or not the use of an antibiotic coated catheter will significantly reduce the number of central line related bloodstream infections in children requiring a CVC. This study may also determine if antibiotic coated catheters will be significantly less likely than non-antibiotic coated catheters to allow bacteria to live (colonize) in/on the catheter.
The use of central venous catheters (CVC) is paramount to the care of critically ill children. Thus, in the pediatric intensive care unit (PICU), these catheters are widely used in situations when more than peripheral venous access is necessary. This central access allows the delivery of fluids, e.g, blood, medications, etc. as well as serves as a means to withdraw blood. It has been estimated that more than 250,000 nosocomial bloodstream infections occur each year, with 90% of these associated with the use of CVCs. More recently, the National Nosocomial Infection Surveillance System (NNIS) reported during 1992-2001 CVC-associated bloodstream infections (BSI) in ICU settings occurred at rates of 2.9-11.3 BSI per 1,000 catheter days. The cost of treating CVC related BSI has been estimated to be in excess of $28,000 per catheter. In the adult medical literature, there is strong evidence supporting use of antiseptic or antibiotic coated catheters to reduce the cost of hospitalization for CVC related infections. Cost-benefit studies have suggested that if the baseline incidence of CVC BSI is >0.4 BSI per 1000 catheter days, $59,000 will be saved, 7 cases of BSI will be avoided, and 1 death prevented for every 300 anti-septic impregnated CVCs used.
Detailed description
Catheter related infections are often difficult to treat because the pathogen may form a biofilm that actually embeds itself into the catheter material. Additionally, the catheter hub and skin around this area may be colonized with bacteria. It is by this route that pathogenic organisms migrate to the external surface of the catheter, which then can progress to the intravascular tip. To decrease the risk of CVC associated infections, antibiotic coated catheters have been used. Since 1990, several types of antiseptic or antimicrobial vascular catheters have been developed. These catheters are designed to protect both the external and internal surfaces of the device from colonization of certain bacteria. Raad et al, have demonstrated in a randomized multicenter clinical trial among hospitalized adult patients that CVCs coated with minocycline and rifampin significantly reduced the risk for catheter-related colonization and bloodstream infections[8]. However, there have been no clinical trials reported in the pediatric population on this issue. This study will prospectively compare in a randomized, blinded fashion the use of two Food \& Drug Administration (FDA) approved central venous catheters - an antibiotic coated CVC to non-coated CVC at DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan. Additional major pediatric teaching hospitals may be added at a later time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- all patients ages 21 years or less admitted to the pediatric intensive care unit or general pediatric unit at DeVos Children's Hospital
- research informed consent must be signed
Key exclusion criteria (1 listed)
- known allergy or sensitivity to minocycline, tetracyline, doxycycline, oxytetracycline, demeclocycline, rifampin, rifabutin
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 |
|---|---|---|
| Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter | Device | – |
Primary outcome
to determine if antibiotic coated catheters reduce the risk of catheter associated BSI in children hospitalized in PICU or in inpatient pediatric ward in comparison to non-antibiotic coated catheters.
An infection free interval is defined as beginning with the insertion of the cvc (or, if applicable with the cure of a infection in a catheter that was left in place anbd concluded with one of the outcomes listed
3 secondary outcomes
to determine the bacterial pathogens associated with antibiotic coated CVC BSI and compare these pathogens with those normally associated with non-antibiotic coated CVC
To determine the bacterial pathogens associated with colonization of antibiotic coated catheter tips in comparison to those normally associated with non-antibiotic coated catheter tips.
To determine risk factors associated with CVC BSI
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 8 Apr 2024.
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.
Robert Fitzgerald, MD principal investigator
Helen DeVos Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter in people with Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter, run by Corewell Health West at 1 site in United States.
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 1 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 8 Apr 2024. 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 United States. 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?
to determine if antibiotic coated catheters reduce the risk of catheter associated BSI in children hospitalized in PICU or in inpatient pediatric ward in comparison to non-antibiotic coated catheters.. 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?
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 8 Apr 2024.