NCT03189043

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

June 14, 2017

Last Update Submit

June 14, 2017

Conditions

Healthcare Associated Infection

Outcome Measures

Primary Outcomes (1)

  • Healthcare-Associated Infections

    Healthcare-Associated Infections

    90 days

Secondary Outcomes (1)

  • 30-day Readmission for infection

    90 days

Study Arms (2)

Test

EXPERIMENTAL

Use of antimicrobial surface

Device: Antimicrobial Surface

Control

NO INTERVENTION

No antimicrobial surface

Interventions

Antimicrobial SurfaceDEVICE

Antimicrobial Surface

Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose A Stoute, M.D.

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose A Stoute, M.D.

CONTACT

3017583689jstoute@psu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

July 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share