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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Duke University
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Durham VA Medical Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01803100
First received: February 27, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Bacterial Infection
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Temporal Profile and Bi-directional Transmission of Microorganisms Between Patients and Environmental Surfaces.

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Changes in the Profile of Epidemiologically-Important Organism [ Time Frame: Day 3, 7 and each week after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Change in the Profile of Epidemiologically Important Organism [ Time Frame: Day 3, 7 and each week after enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hospitalized inpatients
Inpatients newly admitted into freshly-cleaned rooms.
Other: No intervention
There is no intervention in this trial
Other Name: There is no intervention in this trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803100

Contacts
Contact: Lauren Knelson 9196844596

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Lauren Knelson, MSPH    919-684-4596      
Principal Investigator: Luke Chen, MBBS MPH         
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27705
Contact: Lauren Knelson, MSPH    919-684-4596      
Principal Investigator: Luke Chen, MBBS MPH         
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
Durham VA Medical Center
Investigators
Principal Investigator: Luke Chen, MBBS MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01803100     History of Changes
Other Study ID Numbers: Pro00036470, 203-1049
Study First Received: February 27, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Bacterial Colonization

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014