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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00370149
First received: August 28, 2006
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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 after cardiac surgery.


Condition Intervention Phase
Infection Control
Device: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM
Device: Cook Incorporated C-UDLM-401J and C-UDLMY-501J
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Incidence of catheter-related bloodstream infection (CRBSI) [ Time Frame: While catheter placed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness of each catheter based on the rate of catheter complications between the two catheters, ICU days, ventilator days, total hospital duration, and antibiotic days [ Time Frame: While catheter placed and hospital admission ] [ Designated as safety issue: No ]
  • Episodes of clinical sepsis and/or infection with identified source other than catheter [ Time Frame: While catheter placed ] [ Designated as safety issue: No ]
  • Death [ Time Frame: Hospital admission ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: September 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-FST) impregnated with minocycline and rifampin
Device: Cook Incorporated C-UDLM-401J and C-UDLM-401J-ABRM
Patients randomized to this arm will have the central venous catheter inserted intraoperatively
Placebo Comparator: 2
Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 12 cm long, (C-UDLMY-501J)
Device: Cook Incorporated C-UDLM-401J and C-UDLMY-501J
Patients randomized to this arm will have the central venous catheter inserted intraoperatively

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370149

Locations
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Elaine G. Cox, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00370149     History of Changes
Other Study ID Numbers: 0512-37
Study First Received: August 28, 2006
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Catheter-Related Infections
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 29, 2014