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

Healthcare Associated Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03189043
• Other study ID #: 7371
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 14, 2017
• Last updated: June 14, 2017
• Start date: July 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: June 2017
• Source: Aionx, Inc.
• Contact: Jose A Stoute, M.D.
• Phone: 3017583689
• Email: jstoute[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infection
• Infection

Intervention

Device:
• Antimicrobial Surface
Antimicrobial Surface

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aionx, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare-Associated Infections	Healthcare-Associated Infections	90 days
Secondary	30-day Readmission for infection		90 days