Clinical trial NCT00370149: Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infection Prevention
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-08-30
Enrollment: 326
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility 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

Primary outcomes:
measure: Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
timeFrame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Secondary outcomes:
measure: Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
timeFrame: Participants were followed for the duration of hospital stay, an average of 6 days.
measure: Death
timeFrame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Elaine G. Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox EG, Knoderer CA, Jennings A, Brown JW, Rodefeld MD, Walker SG, Turrentine MW. A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients. J Pediatric Infect Dis Soc. 2013 Mar;2(1):67-70. doi: 10.1093/jpids/pis066. Epub 2012 Jul 4.