Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients

Conditions
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Infection Prevention

Intervention / Treatment
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* Device: Antibiotic-impregnated Catheters (M/R)
* Device: Non-impregnated Catheters (C/S)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic-impregnated Catheters (M/R)<br>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). | Device: Antibiotic-impregnated Catheters (M/R)<br>* 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.<br>|
| Placebo Comparator: Non-impregnated Catheter (C/S)<br>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). | Device: Non-impregnated Catheters (C/S)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days | 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. | Participants were followed for the duration of the hospital stay, an average of 6 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter | A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC. | Participants were followed for the duration of hospital stay, an average of 6 days. | 
| Death | Patient Death during hospitalization. | Participants were followed for the duration of the hospital stay, an average of 6 days. |