Back to resultsControlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Primary Purpose
Healthcare Associated Infection
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Antimicrobial Surface
Sponsored by
About this trial
This is an interventional prevention trial for Healthcare Associated Infection
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test
Control
Arm Description
Use of antimicrobial surface
No antimicrobial surface
Outcomes
Primary Outcome Measures
Healthcare-Associated Infections
Healthcare-Associated Infections
Secondary Outcome Measures
30-day Readmission for infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189043
Brief Title
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Official Title
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aionx, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Use of antimicrobial surface
Arm Title
Control
Arm Type
No Intervention
Arm Description
No antimicrobial surface
Intervention Type
Device
Intervention Name(s)
Antimicrobial Surface
Intervention Description
Antimicrobial Surface
Primary Outcome Measure Information:
Title
Healthcare-Associated Infections
Description
Healthcare-Associated Infections
Time Frame
90 days
Secondary Outcome Measure Information:
Title
30-day Readmission for infection
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Stoute, M.D.
Phone
3017583689
Email
jstoute@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Stoute, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
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