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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803100
First Posted: March 4, 2013
Last Update Posted: October 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of North Carolina, Chapel Hill
Durham VA Medical Center
Information provided by (Responsible Party):
Duke University
  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.

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 ]

Secondary Outcome Measures:
  • Time to Change in the Profile of Epidemiologically Important Organism [ Time Frame: Day 3, 7 and each week after enrollment ]

Biospecimen Retention:   Samples Without DNA
Swabs from nares, oropharynx, axillae, peri-rectal. Fecal specimens

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: October 2015
Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803100


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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01803100     History of Changes
Other Study ID Numbers: Pro00036470
203-1049 ( Other Grant/Funding Number: CDC )
First Submitted: February 27, 2013
First Posted: March 4, 2013
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Duke University:
Bacterial Colonization

Additional relevant MeSH terms:
Bacterial Infections