Characterizing and Comparing the Profile of Microorganisms From Specific Body Sites and Environmental Surfaces in Newly Disinfected Patient Rooms

Study of the Temporal Profile and Bi-directional Transmission of Microorganisms Between Patients and Environmental Surfaces.

Overall Aim: To describe and to assess the change in the temporal profile and transmission of microorganisms between patients and environmental surfaces after admission into a newly disinfected room.

Study Activities: Investigators will prospectively and concurrently perform microbiological sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g. bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is already performed in many units of the hospital as standard of care. Infection and readmission related data from enrolled patients will be collected for upto 1 year after enrollment.

Data analysis: Standard surveillance for hospital-acquired infections will be performed by the infection control group of the hospital. The identity and the nature of micro-organisms colonizing the high touch surfaces of rooms and of patient's body sites will be determined and compared. Risks involved is no more than minimal risk.

Study Overview

• Status: Completed
• Conditions: Bacterial Infection
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27705
      • Durham Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cohort will be selected from hospitalized inpatients who are admitted into freshly-cleaned patient rooms and provides consent to participate in this study.

Description

Inclusion Criteria:

• Eligible patients who provide informed consent.

Exclusion Criteria:

• Pediatric patients under 18 years of age,
• Patients who cannot or do not provide consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospitalized inpatients; Inpatients newly admitted into freshly-cleaned rooms.	Other: No intervention; There is no intervention in this trial; Other Names: There is no intervention in this trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the Profile of Epidemiologically-Important Organism	Day 3, 7 and each week after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Change in the Profile of Epidemiologically Important Organism	Day 3, 7 and each week after enrollment

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of North Carolina, Chapel Hill; Durham VA Medical Center
• Investigators: Principal Investigator: Luke Chen, MBBS MPH, Duke University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 27, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Estimate): October 26, 2015
• Last Update Submitted That Met QC Criteria: October 23, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Bacterial Colonization
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: Pro00036470; 203-1049 (Other Grant/Funding Number: CDC)