Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms

NCT05560321 | Completed

• 1 other identifier: Pro00103576
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disinfection

Keywords

Disinfection, contamination

Outcome Measures

Primary Outcomes (1)

• Total room contamination

  Total contamination, in colony-forming units (CFUs) on environmental surfaces on study day 1

  Day 1

Secondary Outcomes (4)

• Clinically important pathogens (CIPs) in samples

  Day 0

• Clinically important pathogens (CIPs) in samples

  Day 1

• Baseline contamination (CFUs and CIPs) of sample areas

  Day 0

• Compliance of routine disinfection

  Day 1

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Sani24; Other: Routine Disinfection

Control

ACTIVE COMPARATOR

Routine disinfection completed by hospital staff

Other: Routine Disinfection

Interventions

Sani24 OTHER

Disinfectant

Intervention

Routine Disinfection OTHER

Routine disinfection at the study hospital

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• Inpatient rooms housing adult patients on contact precautions

Sponsors & Collaborators

• Duke University: lead
• PDI Healthcare Inc.: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 36378308 DERIVED

Study Officials

• Nick Turner, MD

  Duke School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Each participant's inpatient room was enrolled in both the intervention and control arms at the same time.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 29, 2022
• Study Start: August 22, 2019
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)