Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
January 27, 2016 updated by: Indiana University School of Medicine
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
326
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Antibiotic-impregnated Catheters (M/R)
Interventions is insertion intra-operatively of catheters impregnated with minocycline and rifampin to determine if their is a therapeutic difference between this catheter and the placebo (non-impregnated) catheter.
The catheters are sized to accommodate children in different size ranges: Cook Inc.
Double Lumen 4 Fr., 8 cm long, (C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
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Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively.
The catheters are sized to accommodate children in different size ranges.
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Placebo Comparator: Non-impregnated Catheter (C/S)
Intervention is insertion intra-operatively of conventional, non-impregnated catheters.
There are two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long (C-UDLM-501J-RSC).
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Patients randomized to this arm will have the central venous catheter inserted intra-operatively.
The catheters are sized to accommodate children in different size ranges.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
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Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3.
No apparent source for the bloodstream infection except for the catheter.
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Participants were followed for the duration of the hospital stay, an average of 6 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
Time Frame: Participants were followed for the duration of hospital stay, an average of 6 days.
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A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
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Participants were followed for the duration of hospital stay, an average of 6 days.
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Death
Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
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Patient Death during hospitalization.
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Participants were followed for the duration of the hospital stay, an average of 6 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Elaine G. Cox, MD, Indiana University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 28, 2006
First Submitted That Met QC Criteria
August 29, 2006
First Posted (Estimate)
August 30, 2006
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
January 27, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0512-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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