Official Title: “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 after cardiac surgery.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

The standard CVL is now commonly used for infants, children, and adults. The antibiotic-coated CVL is a newer CVL 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 CVL for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVL for infants and children due to lack of research on this CVL in infants and children.

Intervention(s) in this Clinical Trial

• Device: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM
  • Patients randomized to this arm will have the central venous catheter inserted intraoperatively
• Device: Cook Incorporated C-UDLM-401J and C-UDLMY-501J
  • Patients randomized to this arm will have the central venous catheter inserted intraoperatively

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-FST) impregnated with minocycline and rifampin
• Placebo Comparator: 2
  • Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 12 cm long, (C-UDLMY-501J)

Primary Measures

• Incidence of catheter-related bloodstream infection (CRBSI)
  • Time Frame: While catheter placed
    Safety Issue?: No

Secondary Measures

• Cost-effectiveness of each catheter based on the rate of catheter complications between the two catheters, ICU days, ventilator days, total hospital duration, and antibiotic days
  • Time Frame: While catheter placed and hospital admission
    Safety Issue?: No
• Episodes of clinical sepsis and/or infection with identified source other than catheter
  • Time Frame: While catheter placed
    Safety Issue?: No
• Death
  • Time Frame: Hospital admission
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Indiana University School of Medicine

Overall Clinical Trial Officials and Contacts

Elaine G. Cox, MD Principal Investigator Indiana University School of Medicine  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00370149

Study ID Number: 0512-37

ClinicalTrials.gov Identifier: NCT00370149

Health Authority: United States: Institutional Review Board