Study of Catheter-Related Infections Using Antibiotic-Coated Versus Conventional Catheters in Children - Full Text View

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00370149

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 IV

MedlinePlus related topics: Antibiotics Surgery

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	580
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
1: Active Comparator 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
2: Placebo Comparator 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 CVL is now commonly used for infants, children, and adults. The antibiotic-coated CVL is a newer CVL 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 CVL for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVL for infants and children due to lack of research on this CVL 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

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 School of Medicine ( Elaine Cox, MD )
Study ID Numbers:	0512-37
Study First Received:	August 28, 2006
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00370149 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Bacterial Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009