Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00202813 |
| Other study ID # |
2003-104 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 2003 |
| Est. completion date |
October 2005 |
Study information
| Verified date |
April 2024 |
| Source |
Spectrum Health Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
