Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
June 14, 2017 updated by: Dr. Jose Stoute, Aionx, Inc.
This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10000
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Admission to a single occupancy room in a participating floor at Hershey Medical Center
Exclusion Criteria:
- Refusal to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test
Use of antimicrobial surface
|
Antimicrobial Surface
|
|
No Intervention: Control
No antimicrobial surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare-Associated Infections
Time Frame: 90 days
|
Healthcare-Associated Infections
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
30-day Readmission for infection
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jose A Stoute, M.D., Milton S. Hershey Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
June 14, 2017
First Submitted That Met QC Criteria
June 14, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 14, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7371
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.