NCT00370149

Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children

A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery.

Detailed description

The standard central venous catheter (CVC) is now commonly used for infants, children, and adults. The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) support use of the antibiotic-coated CVC for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children.

Conditions

• Infection Prevention

Interventions

Type	Name	Description
DEVICE	Antibiotic-impregnated Catheters (M/R)	Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
DEVICE	Non-impregnated Catheters (C/S)	Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-08-30
• Last updated: 2016-02-24
• Results posted: 2016-02-24

Locations

1 site across 1 country: United States