NCT01765738

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 18, 2018

Status Verified

September 1, 2016

Enrollment Period

3.6 years

First QC Date

January 8, 2013

Last Update Submit

June 14, 2018

Conditions

Peripherally Inserted Central Catheters

Keywords

PICC

Outcome Measures

Primary Outcomes (1)

  • Infection rate

    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.

    60 days

Study Arms (2)

Antibiotic coated PICC

ACTIVE COMPARATOR

Cook Medical Spectrum Turbo-Ject Minocycline/Rifampin Power-Injectable PICC (5fr double lumen or 6fr triple lumen)

Device: PICC (Cook, Bard)

Non-antibiotic coated PICC

ACTIVE COMPARATOR

Bard Access PowerPICC Power Injection PICCs (6fr double lumen or 6fr. triple lumen)

Device: PICC (Cook, Bard)

Interventions

PICC (Cook, Bard)DEVICE

Comparison of antibiotic coated PICC vs. non-coated PICC

Also known as: Minocycline/Rifampin Power-Injectable PICC, PowerPICC Power Injection PICCs
Antibiotic coated PICCNon-antibiotic coated PICC

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • J. Bayne Selby, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 18, 2018

Record last verified: 2016-09

Locations

US(1)