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

Indiana University School of Medicine

Status and phase: Terminated; Phase 4

Conditions: Infection Prevention

Treatments: Device: Antibiotic-impregnated Catheters (M/R); Device: Non-impregnated Catheters (C/S)

Study type: Interventional

Funder types: Other

Identifiers

NCT00370149

0512-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 326 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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326 participants in 2 patient groups, including a placebo group

Antibiotic-impregnated Catheters (M/R)

Active Comparator group

Description:

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).

Treatment:

Device: Antibiotic-impregnated Catheters (M/R)

Non-impregnated Catheter (C/S)

Placebo Comparator group

Description:

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).

Treatment:

Device: Non-impregnated Catheters (C/S)