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

NCT00370149 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2016-02-24

Study results available
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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.

Conditions

  • Infection Prevention

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Elaine G. Cox, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370149 on ClinicalTrials.gov