Status:
TERMINATED
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
Lead Sponsor:
Indiana University School of Medicine
Conditions:
Infection Prevention
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief 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 impregnate...
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 Admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00370149
Start Date
September 1 2006
End Date
May 1 2010
Last Update
February 24 2016
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202