Study of Catheter Related Infections Using Antibiotic-Coated vs. Conventional Catheters in Children
Information source: Indiana University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Venous Catheter Related Infections
Intervention: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM (Device); Cook Incorporated C-UDLM-401J and C-UDLMY-501J (Device)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Elaine G Cox, MD, Principal Investigator, Affiliation: Indiana University School of Medicine
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 after cardiac surgery.
Clinical Details
Official title: A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-Impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of catheter-related bloodstream infection (CRBSI)
Secondary outcome: 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.Episodes of clinical sepsis and/or infection with identified source other than catheter Death
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Riley Hospital for Children, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: September 2006
Ending date: August 2010
Last updated: November 29, 2007
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