DisinfectionNCT05560321
Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms
A study testing Sani24 and Routine Disinfection in people with Disinfection, run by Duke University at 1 site in United States.
Trial summary
To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning. 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 and Routine Disinfection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 17 Mar 2022
- 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
- Inpatient rooms housing adult patients on contact precautions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning.
Read the detailed description
The study Investigator will evaluate the effectiveness of a) adding sani24 to the standard daily cleaning and b) routine daily disinfection in acute care hospital rooms to measure the reduction in bioburden. In other words, the study aims to answer the following research question: does the addition of an additional disinfection technology (Sani24) decrease the environmental bioburden in inpatient hospital compared to routine disinfection?
This trial was conducted in acute care hospital rooms at Duke University Hospital in Durham, North Carolina from November 2021 to March 2022. Room surfaces were divided in two (e.g., right vs. left), allowing each patient room to serve as its own control. The intervention was a quaternary ammonium salt-based 24-hour continuously active germicidal wipe, Sani-24 (PDI Healthcare, Woodcliff, NJ) that was applied in addition to routine disinfection. The control arm received no intervention beyond routine disinfection. Environmental services were blinded to study arms and no changes to routine cleaning protocols occurred during the study period. Room contamination was measured immediately before the application of the disinfectant (study day 0) and 24-hours later (day 1). Secondary outcomes included evaluation for clinically important pathogens (CIP), including methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE)
- Conditions
- Disinfection
- Being tested
- Sani24, 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
Disinfectant
Routine DisinfectionOther
Routine disinfection at the study hospital
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team Receives: Other: Sani24; Other: Routine Disinfection |
| 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.
Total room contamination
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1
Measured: Day 1
Secondary outcomes (4)
Clinically important pathogens (CIPs) in samples
Proportion of samples positive for individual CIP
Measured: Day 0
Clinically important pathogens (CIPs) in samples
Proportion of samples positive for individual CIP
Measured: Day 1
Baseline contamination (CFUs and CIPs) of sample areas
Similarity of baseline contamination measured in CFUs and proportion of samples positive for CIPs between sample area sides on study day 0 before application of the intervention
Measured: Day 0
Compliance of routine disinfection
Proportion of sample areas with removed ultraviolet glowing gel on study day 1
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start22 Aug 2019
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 was enrolled in both the intervention and control arms at the same time.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- PDI Healthcare Inc.
- Responsible party
- Sponsor
- Investigators
- Nick Turner, MD, Principal investigator, Duke School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560321
- Sponsor's protocol ID
- Pro00103576
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 29 Sep 2022
- 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.
Publications
Warren BG, Barrett A, Graves A, King C, Turner NA, Anderson DJ. An Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242131. doi: 10.1001/jamanetworkopen.2022.42131.
PubMed 36378308
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms
- ClinicalTrials.gov ID
- NCT05560321
- Acronym / sponsor ID
- Pro00103576
- Conditions
- Disinfection
- Keywords
- Disinfection, contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- PDI Healthcare Inc.
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 29 Sep 2022 (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.
To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning.
Detailed description
The study Investigator will evaluate the effectiveness of a) adding sani24 to the standard daily cleaning and b) routine daily disinfection in acute care hospital rooms to measure the reduction in bioburden. In other words, the study aims to answer the following research question: does the addition of an additional disinfection technology (Sani24) decrease the environmental bioburden in inpatient hospital compared to routine disinfection?
This trial was conducted in acute care hospital rooms at Duke University Hospital in Durham, North Carolina from November 2021 to March 2022. Room surfaces were divided in two (e.g., right vs. left), allowing each patient room to serve as its own control. The intervention was a quaternary ammonium salt-based 24-hour continuously active germicidal wipe, Sani-24 (PDI Healthcare, Woodcliff, NJ) that was applied in addition to routine disinfection. The control arm received no intervention beyond routine disinfection. Environmental services were blinded to study arms and no changes to routine cleaning protocols occurred during the study period. Room contamination was measured immediately before the application of the disinfectant (study day 0) and 24-hours later (day 1). Secondary outcomes included evaluation for clinically important pathogens (CIP), including methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant's inpatient room was enrolled in both the intervention and control arms at the same time.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sani24, Other: Routine DisinfectionApplication of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) 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 (1 listed)
- Inpatient rooms housing adult patients on contact precautions
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sani24Disinfectant | Other | Intervention |
| Routine DisinfectionRoutine disinfection at the study hospital | Other | Control, Intervention |
Primary outcome
Total room contamination
Time frame: Day 1
Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1
4 secondary outcomes
Clinically important pathogens (CIPs) in samples
Time frame: Day 0
Clinically important pathogens (CIPs) in samples
Time frame: Day 1
Baseline contamination (CFUs and CIPs) of sample areas
Time frame: Day 0
Compliance of routine disinfection
Time frame: Day 1
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 29 Sep 2022.
- Derived from this study: PubMed 36378308Warren BG, Barrett A, Graves A, King C, Turner NA, Anderson DJ. An Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242131. doi: 10.1001/jamanetworkopen.2022.42131.
- 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.
Nick Turner, MD principal investigator
Duke School of Medicine
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 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 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: finished, as of the sponsor's last update on 29 Sep 2022. 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?
Total room contamination (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560321, which also lists 1 linked publication.
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 29 Sep 2022.