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Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

This study is not yet open for participant recruitment.
Verified January 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
J. Bayne Selby, Jr., Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01765738
First received: January 8, 2013
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.


Condition Intervention Phase
Peripherally Inserted Central Catheters
 Device: PICC (Cook, Bard)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Double Blind Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Infection rate [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    Records will be reviewed up to 60 days post PICC line procedure to assess whether catheter was removed prematurely for infection and results of cultures on any catheters removed.


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotic coated PICC
Cook Medical Spectrum Turbo-Ject Minocycline/Rifampin Power-Injectable PICC (5fr double lumen or 6fr triple lumen)
 Device: PICC (Cook, Bard)
Comparison of antibiotic coated PICC vs. non-coated PICC
Other Names:
  • Minocycline/Rifampin Power-Injectable PICC
  • PowerPICC Power Injection PICCs
Active Comparator: Non-antibiotic coated PICC
Bard Access PowerPICC Power Injection PICCs (6fr double lumen or 6fr. triple lumen)
 Device: PICC (Cook, Bard)
Comparison of antibiotic coated PICC vs. non-coated PICC
Other Names:
  • Minocycline/Rifampin Power-Injectable PICC
  • PowerPICC Power Injection PICCs

Detailed Description:

All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 18 years of age
  • Have been scheduled for a medically necessary PICC placement

Exclusion Criteria:

  • Less than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765738

Locations
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Tina Cooper, BA     843-792-1930     cooperti@musc.edu    
Sub-Investigator: Chris Erikson, MD            
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: J. Bayne Selby, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: J. Bayne Selby, Jr., Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01765738     History of Changes
Other Study ID Numbers: PICC Line Comparison
Study First Received: January 8, 2013
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
PICC

Additional relevant MeSH terms:
Anti-Bacterial Agents
Minocycline
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013