Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

NCT05739955 | Recruiting

• 1 other identifier: Pro00112526
• Study Type: interventional
• Target: 918
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disinfection

Keywords

Disinfection; Contamination

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (day 1), day 2

Secondary Outcomes (11)

• Change in total room contamination

  Day 2, Day 3, Day 4

• Frequency of daily disinfection by EVS or unit personnel (control arm) and study personnel (intervention arms)

  Day 2, Day 3, Day 4

• Total room contamination with epidemiologically important pathogens (EIP)

  Day 1, Day 2, Day 3, Day 4

• Total contamination on room bed rails

  Day 1, Day 2, Day 3, Day 4

• Total contamination on room footboards

  Day 1, Day 2, Day 3, Day 4

Study Arms (3)

Sani24

EXPERIMENTAL

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

Other: Sani24

Standard EPA-registered disinfectant

EXPERIMENTAL

Application of standard EPA-registered disinfectant by study team

Other: Standard EPA-registered disinfectant

Control

ACTIVE COMPARATOR

Routine disinfection completed by hospital staff

Other: Routine Disinfection

Interventions

Sani24 OTHER

24-hour continuously acting quaternary ammonium salt disinfectant

Sani24

Standard EPA-registered disinfectant OTHER

Standard EPA-registered disinfectant

Standard EPA-registered disinfectant

Routine Disinfection OTHER

Routine disinfection at the study hospital

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

• Deverick Anderson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda M Graves, MPH

CONTACT

919-681-7957; amanda.m.graves@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple blind - exception of the study team member applying the disinfectant products (intervention 1 or 2)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant's inpatient room are enrolled in one of the interventions and control arms at the same time.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: February 13, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)