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

Infection Prevention Clinical Trial

Official title:

A Randomized, Controlled Trial of Catheter Related Infectious Event Rates Using Antibiotic-impregnated Catheters vs. Conventional Catheters in Pediatric Cardiovascular Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00370149
• Other study ID #: 0512-37
• Status: Terminated
• Phase: Phase 4
• First received: August 28, 2006
• Last updated: January 27, 2016
• Start date: September 2006
• Est. completion date: May 2010

Study information

• Verified date: January 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 326
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter-Related Infections
• Infection Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cox EG, Knoderer CA, Jennings A, Brown JW, Rodefeld MD, Walker SG, Turrentine MW. A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Su — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days	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.	Participants were followed for the duration of the hospital stay, an average of 6 days.	No
Secondary	Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter	A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.	Participants were followed for the duration of hospital stay, an average of 6 days.	No
Secondary	Death	Patient Death during hospitalization.	Participants were followed for the duration of the hospital stay, an average of 6 days.	No

External Links

•   Riley Childrens Hospital at Indiana University Health