Healthcare Associated InfectionPhase 2NCT03189043
Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
A Phase 2 study testing Antimicrobial Surface in people with Healthcare Associated Infection, run by Aionx, Inc..
Trial summary
This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infection
- What is being tested?
- Antimicrobial Surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to a single occupancy room in a participating floor at Hershey Medical Center
Who cannot join
- Refusal to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
This is a controlled open label efficacy study of Aionx antimicrobial surface for the prevention of healthcare-associated infections.
Read the 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.
- Conditions
- Healthcare Associated Infection
- Being tested
- Antimicrobial Surface
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial SurfaceDevice
Antimicrobial Surface
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Use of antimicrobial surface Receives: Device: Antimicrobial Surface |
| Control | No intervention | No antimicrobial surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare-Associated Infections
Healthcare-Associated Infections
Measured: 90 days
Secondary outcomes (1)
30-day Readmission for infection
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aionx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Jose Stoute, Milton S. Hershey Medical Center
- Investigators
- Jose A Stoute, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189043
- Sponsor's protocol ID
- 7371
- Status last verified
- Jun 2017
- First submitted
- 14 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Crossover Study of AIONX Antimicrobial Surface for the Prevention of Healthcare-associated Infections
- ClinicalTrials.gov ID
- NCT03189043
- Acronym / sponsor ID
- 7371
- Conditions
- Healthcare Associated Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Aionx, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Antimicrobial SurfaceUse of antimicrobial surface |
| Control | No intervention | –No antimicrobial surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to a single occupancy room in a participating floor at Hershey Medical Center
Key exclusion criteria (1 listed)
- Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial SurfaceAntimicrobial Surface | Device | Test |
Primary outcome
Healthcare-Associated Infections
Time frame: 90 days
Healthcare-Associated Infections
1 secondary outcome
30-day Readmission for infection
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Stoute, M.D. principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antimicrobial Surface in people with Healthcare Associated Infection, run by Aionx, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose A Stoute, M.D. (3017583689, jstoute@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare-Associated Infections (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.