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

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.

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.

Inclusion Criteria:

• Age < 18 years
• Cardiovascular surgery patient with a case complexity warranting CVC placement longer than 3 days
• Study devices of appropriate size for patient use without modification
• Informed consent obtained prior to patient entering the operating room

Exclusion Criteria:

• Age ≥ 18 years
• Drug allergy to minocycline, other tetracyclines, or rifampin
• Ventricular assist device (VAD) therapy
• Extracorporeal membrane oxygenation (ECMO) therapy
• Patients undergoing cardiac transplant
• Any active infection or being treated for bacteremia at the time of randomization