Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

NCT ID: NCT05739955

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

918 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2026-02-28

Brief Summary

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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

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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

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Disinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Triple blind - exception of the study team member applying the disinfectant products (intervention 1 or 2)

Study Groups

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Sani24

Application of a 24-hour continuously acting quaternary ammonium salt disinfectant: Sani24 (PDI Healthcare Inc.) by study team

Group Type EXPERIMENTAL

Sani24

Intervention Type OTHER

24-hour continuously acting quaternary ammonium salt disinfectant

Standard EPA-registered disinfectant

Application of standard EPA-registered disinfectant by study team

Group Type EXPERIMENTAL

Standard EPA-registered disinfectant

Intervention Type OTHER

Standard EPA-registered disinfectant

Control

Routine disinfection completed by hospital staff

Group Type ACTIVE_COMPARATOR

Routine Disinfection

Intervention Type OTHER

Routine disinfection at the study hospital

Interventions

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Sani24

24-hour continuously acting quaternary ammonium salt disinfectant

Intervention Type OTHER

Standard EPA-registered disinfectant

Standard EPA-registered disinfectant

Intervention Type OTHER

Routine Disinfection

Routine disinfection at the study hospital

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deverick Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda M Graves, MPH

Role: CONTACT

919-681-7957

Facility Contacts

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Amanda M Graves, MPH

Role: primary

919-681-7957

Other Identifiers

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Pro00112526

Identifier Type: -

Identifier Source: org_study_id

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