Controlled Crossover Study of AIONX Antimicrobial Surface... | NCT03189043

Studies
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections

NCT03189043

Sponsor

Aionx, Inc.

Status

Unknown status

Last Update Posted

Jun 16, 2017Actual

Enrollment

10,000Estimated

Phase

Phase 2

Conditions

Healthcare Associated Infection

Interventions

Antimicrobial Surface

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Estimated

Primary Completion Date

Oct 1, 2017Estimated

Completion Date

Oct 1, 2017Estimated

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 16, 2017Actual

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

Jun 14, 2017

Last Update Posted Date

Jun 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.

Detailed Description

The study is an open label controlled efficacy trial of Aionx patented antimicrobial surface for the prevention of healthcare-associated infections (HAIs). It will take place at Penn State Hershey. Half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. The remaining rooms will serve as controls. Data on HAIs will be gathered for all the patients admitted to the rooms during the duration of the study. After 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. The duration of the study will be for a minimum of 90 days.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	Use of antimicrobial surface	Device: Antimicrobial Surface
Control	No Intervention	No antimicrobial surface

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antimicrobial Surface	Device	Antimicrobial Surface	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healthcare-Associated Infections	Healthcare-Associated Infections	90 days

Secondary Outcomes

Measure	Description	Time Frame
30-day Readmission for infection		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admission to a single occupancy room in a participating floor at Hershey Medical Center

Exclusion Criteria:

Refusal to participate in the study.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jose A Stoute, M.D.	Contact	3017583689		jstoute@psu.edu

Overall Officials

Name	Affiliation	Role
Jose A Stoute, M.D.	Milton S. Hershey Medical Center	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D003428	Cross Infection

Ancestor Terms

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided