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

NCT01803100 | Completed

• 2 other identifiers: Pro00036470203-1049
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bacterial Infection

Keywords

Bacterial Colonization

Outcome Measures

Primary Outcomes (1)

• Changes in the Profile of Epidemiologically-Important Organism

  Day 3, 7 and each week after enrollment

Secondary Outcomes (1)

• Time to Change in the Profile of Epidemiologically Important Organism

  Day 3, 7 and each week after enrollment

Study Arms (1)

Hospitalized inpatients

Inpatients newly admitted into freshly-cleaned rooms.

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this trial

Also known as: There is no intervention in this trial

Hospitalized inpatients

Eligibility Criteria

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

You may qualify if:

• Eligible patients who provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator
• Durham VA Medical Center: collaborator

Study Sites (2)

Durham Regional Hospital

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Swabs from nares, oropharynx, axillae, peri-rectal. Fecal specimens

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Luke Chen, MBBS MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 4, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (2)