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

Bacterial Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803100
• Other study ID #: Pro00036470
• Secondary ID: 203-1049
• Status: Completed
• Phase: N/A
• First received: February 27, 2013
• Last updated: October 23, 2015
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Intervention

Other:
• No intervention
There is no intervention in this trial

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Regional Hospital	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Durham VA Medical Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Profile of Epidemiologically-Important Organism		Day 3, 7 and each week after enrollment	No
Secondary	Time to Change in the Profile of Epidemiologically Important Organism		Day 3, 7 and each week after enrollment	No