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

This study has been terminated.
(Blinded interim analysis resulted in early termination of the study.)
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00370149
First received: August 28, 2006
Last updated: January 27, 2016
Last verified: January 2016
  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 (CABSI) after cardiac surgery.

Condition Intervention Phase
Infection Prevention
Device: Antibiotic-impregnated Catheters (M/R)
Device: Non-impregnated Catheters (C/S)
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 Infections (CRBSI) Per 1000 Catheter Days [ Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days. ] [ Designated as safety issue: No ]
    Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.


Secondary Outcome Measures:
  • Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter [ Time Frame: Participants were followed for the duration of hospital stay, an average of 6 days. ] [ Designated as safety issue: No ]
    A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.

  • Death [ Time Frame: Participants were followed for the duration of the hospital stay, an average of 6 days. ] [ Designated as safety issue: No ]
    Patient Death during hospitalization.


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: 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).
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.
Placebo Comparator: 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).
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.

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   (Child)
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

Additional Information:
Publications:
Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00370149     History of Changes
Other Study ID Numbers: 0512-37 
Study First Received: August 28, 2006
Results First Received: October 19, 2015
Last Updated: January 27, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 22, 2016