Viewing Study NCT00202813



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Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00202813
Status: COMPLETED
Last Update Posted: 2024-04-08
First Post: 2005-09-13

Brief Title: Study of the Use of Coated Venous Catheters in the Critically Ill Child
Sponsor: Spectrum Health Hospitals
Organization: Spectrum Health Hospitals

Study Overview

Official Title: The Use of Antibiotic-coated Venous Catheters in the Critically Ill Child Reducing the Rate of Bloodstream Related Infections
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 inon 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 eg blood medications etc as well as serves as a means to withdraw blood It has been estimated that more than 250000 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 29-113 BSI per 1000 catheter days The cost of treating CVC related BSI has been estimated to be in excess of 28000 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 04 BSI per 1000 catheter days 59000 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 infections8 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 Childrens Hospital at Spectrum Health Grand Rapids Michigan Additional major pediatric teaching hospitals may be added at a later time

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None