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

NCT00370149 | Terminated Phase 4 Results DMC

• 1 other identifier: 0512-37
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter

  Participants were followed for the duration of hospital stay, an average of 6 days.

• Death

  Participants were followed for the duration of the hospital stay, an average of 6 days.

Study Arms (2)

Antibiotic-impregnated Catheters (M/R)

ACTIVE COMPARATOR

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)

Non-impregnated Catheter (C/S)

PLACEBO COMPARATOR

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)

Interventions

Antibiotic-impregnated Catheters (M/R) DEVICE

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.

Antibiotic-impregnated Catheters (M/R)

Non-impregnated Catheters (C/S) DEVICE

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.

Non-impregnated Catheter (C/S)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related 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 Surgery Patients. J Pediatric Infect Dis Soc. 2013 Mar;2(1):67-70. doi: 10.1093/jpids/pis066. Epub 2012 Jul 4.

  PMID: 26619445 RESULT

Limitations and Caveats

A blinded interim analysis by an independent Data Safety Monitoring Board resulted in early termination of the study: of 288 evaluable patients, the rates of CRBSI and line-related complications were similar between the 2 groups.

Results Point of Contact

• Title: Elaine G Cox, MD
• Organization: Riley Hospital for Children

elmcox@iu.edu

317-944-7260

Study Officials

• Elaine G. Cox, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 30, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)