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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-05-31

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.

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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.

Conditions

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Infection Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Antibiotic-impregnated Catheters (M/R)

Intervention Type DEVICE

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.

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).

Group Type PLACEBO_COMPARATOR

Non-impregnated Catheters (C/S)

Intervention Type DEVICE

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.

Interventions

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Antibiotic-impregnated Catheters (M/R)

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.

Intervention Type DEVICE

Non-impregnated Catheters (C/S)

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.

Intervention Type DEVICE

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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No