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

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ClinicalTrials.gov Identifier: NCT03189043
Recruitment Status : Unknown
Verified June 2017 by Dr. Jose Stoute, Milton S. Hershey Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Jose Stoute, Milton S. Hershey Medical Center

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

Condition or disease Intervention/treatment Phase
Healthcare Associated Infection Device: Antimicrobial Surface Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Test
Use of antimicrobial surface
Device: Antimicrobial Surface
Antimicrobial Surface

No Intervention: Control
No antimicrobial surface



Primary Outcome Measures :
  1. Healthcare-Associated Infections [ Time Frame: 90 days ]
    Healthcare-Associated Infections


Secondary Outcome Measures :
  1. 30-day Readmission for infection [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189043


Contacts
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Contact: Jose A Stoute, M.D. 3017583689 jstoute@psu.edu

Sponsors and Collaborators
Aionx, Inc.
Investigators
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Principal Investigator: Jose A Stoute, M.D. Milton S. Hershey Medical Center

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Responsible Party: Dr. Jose Stoute, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03189043     History of Changes
Other Study ID Numbers: 7371
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents