Study to Compare CAUTI Rates Following ERASE CAUTI Tray N... | NCT02101762

Studies
Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters

NCT02101762

Sponsor

Medline Industries

Status

Terminated

Last Update Posted

Sep 13, 2016Estimated

Enrollment

756Actual

Phase

Not provided

Conditions

Surgery
Intensive Care Units

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Feb 9, 2012

First Submission Date that Met QC Criteria

Mar 27, 2014

First Posted Date

Apr 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

756Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silver Coated Catheters		Subjects that had previously received silver coated Foley catheters.
ERASE CAUTI Non-Silver Coated Catheters		Subjects that received non-silver catheters from an ERASE CAUTI tray.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Urinary tract infection rates	Infection rate/1000 catheter days.	3-9 months based on size of ICU and catheter usage

Secondary Outcomes

Measure	Description	Time Frame
Catheter use	Number of days catheters used.	Catheter days
Infection Costs	Catheter related charges for infections	Duration of infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age
Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter

Exclusion Criteria:

UTI present upon current hospital admission
Burn patients, transplant patients, or immune-compromised patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects requiring urinary Foley catheters.

Sampling Method

Probability Sample

Name	Affiliation	Role
Ed Drower, MS	Medline Industries	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided