DisinfectionNCT05739955
Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms
A study testing Sani24, Standard EPA-registered disinfectant and Routine Disinfection in people with Disinfection, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disinfection
- What is being tested?
- Sani24, Standard EPA-registered disinfectant and Routine Disinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 18 Nov 2025
- Phase
- Interventional
- 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
- Adult patient admitted to the room
- Patient spent ≥1 night in room prior to enrollment
- Anticipated patient stay of ≥48 hours
- On contact precautions (for any reason) and/or has positive culture for EIP at the time of room admission
Who cannot join
- Patient stay is expect to be <48 hours
- Patient age <18, even if on adult ward
- Patient admitted on respiratory precautions due to coronavirus disease (COVID-19), influenza, or respiratory syncytial virus (RSV)
- Patient on contact precautions due to C. difficile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Impact of Enhanced Daily Disinfection on Environmental Contamination in Acute Care Hospital Rooms: A 3-arm Multicenter Blinded Randomized Controlled Trial
The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice.
Read the detailed description
The study investigator will evaluate the effectiveness of daily disinfection strategies on environmental contamination in acute care hospital rooms.
The trial will be conducted in acute care hospital rooms at Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and the University of North Carolina Medical Center. In each study room, one half will be randomized to the control arm, and the other half will be randomized to one of the two intervention arms. Two separate randomization steps will occur. First, each room will be randomized to Intervention 1 or Intervention 2. Second, the half of the room to which the intervention will be applied (e.g., right vs. left) will be randomly selected. The control arm will receive no interventions. Rooms randomized to the control arm will undergo routine disinfection via existing Environmental Services (EVS) protocols. All study hospitals routinely use EPA-registered disinfectants for low-level disinfection of hospital room surfaces. Intervention 1 is the standard EPA-registered disinfectant to each study surface and will be applied by the study team. Intervention 2 is a quaternary ammonium, salt-based, 24-hour continuously active germicidal wipe (Sani-24®) to each study surface and will be applied by the study team.
Three different methods will be used for disinfection. No changes to baseline and routine disinfection practices will occur during the study. EVS employees at study hospitals will be responsible for the total room cleaning and disinfection throughout the study. Tasks will be separated between study team members to maintain blinding.Room contamination will be measured before the application of the interventions on study day 1 and every 24 hours for 3 subsequent days, for a total of 4 days. Secondary outcomes include evaluation for epidemiologically important pathogens (EIP), including me staphylococcus aureus (MRSA or MSSA), extended spectrum beta-lactamase (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) producing Enterobacterales, vancomycin-resistant Enterococci (VRE), vancomycin-susceptible Enterococci (VSE), Acinetobacter spp., and Pseudomonas aeruginosa.
- Conditions
- Disinfection
- Being tested
- Sani24, Standard EPA-registered disinfectant, Routine Disinfection
- Keywords
- Disinfection, Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sani24Other
24-hour continuously acting quaternary ammonium salt disinfectant
Standard EPA-registered disinfectantOther
Standard EPA-registered disinfectant
Routine DisinfectionOther
Routine disinfection at the study hospital
| Study group | Role | What they receive |
|---|---|---|
| Sani24 | Experimental | Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team Receives: Other: Sani24 |
| Standard EPA-registered disinfectant | Experimental | Application of standard EPA-registered disinfectant by study team Receives: Other: Standard EPA-registered disinfectant |
| Control | Active comparator | Routine disinfection completed by hospital staff Receives: Other: Routine Disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total room contamination in study rooms on study day 2
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study days 1 and 2
Measured: Baseline (day 1), day 2
Secondary outcomes (11)
Change in total room contamination
Total CFU measured on study days 2, 3, and 4
Measured: Day 2, Day 3, Day 4
Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)
Proportion of sample areas with removed ultraviolet glowing gel on study days 2, 3, 4
Measured: Day 2, Day 3, Day 4
Total room contamination with epidemiologically important pathogens (EIP)
Number of samples positive for individual EIP
Measured: Day 1, Day 2, Day 3, Day 4
Total contamination on room bed rails
Total CFU measured from room bed rails on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Total contamination on room footboards
Total CFU measured from room footboards on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Total contamination on room sinks
Total CFU measured from room sinks on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room bed rails
Total EIP measured from room bed rails on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room footboards
Total EIP measured from room footboards on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room sinks
Total EIP measured from room sinks on study days 1, 2, 3, 4
Measured: Day 1, Day 2, Day 3, Day 4
Proportion of positive environmental cultures
Frequency of growth of any organism on any of the surfaces and on each surface.
Measured: Day 1, Day 2, Day 3, Day 4
Proportion of EIP positive environmental cultures
Frequency of EIP growth on any of the surfaces and on each surface.
Measured: Day 1, Day 2, Day 3, Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start13 Feb 2023
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisinfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Deverick Anderson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739955
- Sponsor's protocol ID
- Pro00112526
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of Enhanced Daily Disinfection on Environmental Contamination in Acute Care Hospital Rooms: A 3-arm Multicenter Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05739955
- Acronym / sponsor ID
- Pro00112526
- Conditions
- Disinfection
- Keywords
- Disinfection, Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 22 Feb 2023 (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.
The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice.
Detailed description
The study investigator will evaluate the effectiveness of daily disinfection strategies on environmental contamination in acute care hospital rooms.
The trial will be conducted in acute care hospital rooms at Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and the University of North Carolina Medical Center. In each study room, one half will be randomized to the control arm, and the other half will be randomized to one of the two intervention arms. Two separate randomization steps will occur. First, each room will be randomized to Intervention 1 or Intervention 2. Second, the half of the room to which the intervention will be applied (e.g., right vs. left) will be randomly selected. The control arm will receive no interventions. Rooms randomized to the control arm will undergo routine disinfection via existing Environmental Services (EVS) protocols. All study hospitals routinely use EPA-registered disinfectants for low-level disinfection of hospital room surfaces. Intervention 1 is the standard EPA-registered disinfectant to each study surface and will be applied by the study team. Intervention 2 is a quaternary ammonium, salt-based, 24-hour continuously active germicidal wipe (Sani-24®) to each study surface and will be applied by the study team.
Three different methods will be used for disinfection. No changes to baseline and routine disinfection practices will occur during the study. EVS employees at study hospitals will be responsible for the total room cleaning and disinfection throughout the study. Tasks will be separated between study team members to maintain blinding.Room contamination will be measured before the application of the interventions on study day 1 and every 24 hours for 3 subsequent days, for a total of 4 days. Secondary outcomes include evaluation for epidemiologically important pathogens (EIP), including me staphylococcus aureus (MRSA or MSSA), extended spectrum beta-lactamase (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) producing Enterobacterales, vancomycin-resistant Enterococci (VRE), vancomycin-susceptible Enterococci (VSE), Acinetobacter spp., and Pseudomonas aeruginosa.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.
| Arm | Type | Receives |
|---|---|---|
| Sani24 | Experimental | Other: Sani24Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team |
| Standard EPA-registered disinfectant | Experimental | Other: Standard EPA-registered disinfectantApplication of standard EPA-registered disinfectant by study team |
| Control | Active comparator | Other: Routine DisinfectionRoutine disinfection completed by hospital staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient admitted to the room
- Patient spent ≥1 night in room prior to enrollment
- Anticipated patient stay of ≥48 hours
- On contact precautions (for any reason) and/or has positive culture for EIP at the time of room admission
Key exclusion criteria (4 listed)
- Patient stay is expect to be <48 hours
- Patient age <18, even if on adult ward
- Patient admitted on respiratory precautions due to coronavirus disease (COVID-19), influenza, or respiratory syncytial virus (RSV)
- Patient on contact precautions due to C. difficile
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 |
|---|---|---|
| Sani2424-hour continuously acting quaternary ammonium salt disinfectant | Other | Sani24 |
| Standard EPA-registered disinfectantStandard EPA-registered disinfectant | Other | Standard EPA-registered disinfectant |
| Routine DisinfectionRoutine disinfection at the study hospital | Other | Control |
Primary outcome
Change in total room contamination in study rooms on study day 2
Time frame: Baseline (day 1), day 2
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study days 1 and 2
11 secondary outcomes
Change in total room contamination
Time frame: Day 2, Day 3, Day 4
Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)
Time frame: Day 2, Day 3, Day 4
Total room contamination with epidemiologically important pathogens (EIP)
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room bed rails
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room footboards
Time frame: Day 1, Day 2, Day 3, Day 4
Total contamination on room sinks
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room bed rails
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room footboards
Time frame: Day 1, Day 2, Day 3, Day 4
Total EIP contamination on room sinks
Time frame: Day 1, Day 2, Day 3, Day 4
Proportion of positive environmental cultures
Time frame: Day 1, Day 2, Day 3, Day 4
Proportion of EIP positive environmental cultures
Time frame: Day 1, Day 2, Day 3, Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. Participant data will be reported in aggregate.
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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.
Deverick Anderson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sani24, Standard EPA-registered disinfectant and Routine Disinfection in people with Disinfection, run by Duke University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total room contamination in study rooms on study day 2 (time frame: Baseline (day 1), day 2). 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 6 Apr 2026.