Point Prevalence Study of Multidrug-Resistant Organism Carriage by Healthcare Personnel

September 7, 2018 updated by: National Institutes of Health Clinical Center (CC)

Acquisition and transmission of MDROs in healthcare facilities is a major patient safety problem, afflicting in particular the antibiotic-exposed and immunodeficient patient populations. MDRO-colonized patients require isolation to reduce the risk of transmission to other patients, and frequently develop infections from their colonizing organisms.

Most clinically relevant MDROs are carried in the gastrointestinal tract; thus perirectal cultures are frequently the surveillance method used to screen for these pathogens. Surveillance to identify MDRO colonization allows for anticipation and timely initiation of effective treatment of patients who develop infection.

The precise modes of transmission within hospitals are not known, but contamination of the hands of healthcare personnel, patient care equipment, and the healthcare environment are thought to play major roles in transmitting MDRO. Suboptimal hand hygiene can lead to transmission on the hands of staff to other patients or colonization of their own gastrointestinal tract. Few studies have investigated intestinal colonization of healthcare professionals. Transmission of bacteria by healthcare personnel is thought to occur primarily via contaminated hands; we wonder whether gastrointestinal carriage by healthcare personnel also plays a role in nosocomial spread.

This study will screen a self-referred convenience sample of 400 healthcare personnel who have contact with patients or patient culture specimens for fecal carriage of MDRO at one point in time. A control group of 400 NIH employees or contractors who do not have contact with patients or patient specimens will also be screened. Samples will be linked to questionnaires to assess the exposure of staff members to patients or culture specimens with known MDRO colonization or infection. We will use molecular typing techniques to link healthcare personnel isolates to patient or environmental isolates. Finally, the study will be conducted in such a way as to preserve to the greatest extent possible the anonymity of volunteers, using a system of alphanumeric identifiers and unmanned drop boxes for specimen collection.

Study Overview

Status

Completed

Conditions

Detailed Description

Acquisition and transmission of MDROs in healthcare facilities is a major patient safety problem, afflicting in particular the antibiotic-exposed and immunodeficient patient populations. MDRO-colonized patients require isolation to reduce the risk of transmission to other patients, and frequently develop infections from their colonizing organisms.

Most clinically relevant MDROs are carried in the gastrointestinal tract; thus perirectal cultures are frequently the surveillance method used to screen for these pathogens. Surveillance to identify MDRO colonization allows for anticipation and timely initiation of effective treatment of patients who develop infection.

The precise modes of transmission within hospitals are not known, but contamination of the hands of healthcare personnel, patient care equipment, and the healthcare environment are thought to play major roles in transmitting MDRO. Suboptimal hand hygiene can lead to transmission on the hands of staff to other patients or colonization of their own gastrointestinal tract. Few studies have investigated intestinal colonization of healthcare professionals. Transmission of bacteria by healthcare personnel is thought to occur primarily via contaminated hands; we wonder whether gastrointestinal carriage by healthcare personnel also plays a role in nosocomial spread.

This study will screen a self-referred convenience sample of 400 healthcare personnel who have contact with patients or patient culture specimens for fecal carriage of MDRO at one point in time. A control group of 400 NIH employees or contractors who do not have contact with patients or patient specimens will also be screened. Samples will be linked to questionnaires to assess the exposure of staff members to patients or culture specimens with known MDRO colonization or infection. We will use molecular typing techniques to link healthcare personnel isolates to patient or environmental isolates. Finally, the study will be conducted in such a way as to preserve to the greatest extent possible the anonymity of volunteers, using a system of alphanumeric identifiers and unmanned drop boxes for specimen collection.

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Healthcare personnel at the NIH CC who have contact with patients or patient culture specimens will be eligible for study participation. The control group will consist of NIH employees, contractors of the NIH, C or people who work on the Bethesda NIH campus without exposure to patients or patient culture specimens.

EXCLUSION CRITERIA:

Individuals less than 18 years of age and those with any condition that, in the opinion of the principal investigator or designee, contraindicates participation in the study will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of study participants colonized
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Investigators

  • Principal Investigator: Brooke K Decker, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 13, 2013

Primary Completion (Actual)

September 13, 2013

Study Completion (Actual)

January 13, 2017

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

January 13, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 130195
  • 13-CC-0195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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