- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202813
Study of the Use of Coated Venous Catheters in the Critically Ill Child
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Michigan
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Grand Rapids, Michigan, United States, 49503
- DeVos Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
known allergy or sensitivity to minocycline, tetracyline, doxycycline, oxytetracycline, demeclocycline, rifampin, rifabutin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
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to determine the bacterial pathogens associated with antibiotic coated CVC BSI and compare these pathogens with those normally associated with non-antibiotic coated CVC
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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.
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To determine risk factors associated with CVC BSI
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Fitzgerald, MD, Helen DeVos Children's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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