Clinical Trials Directory

Trials / Completed

CompletedNCT01952158

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

Status
Completed
Phase
Study type
Observational
Enrollment
800 (actual)
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2013-09-13
Primary completion
2013-09-13
Completion
2017-01-13
First posted
2013-09-27
Last updated
2018-09-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01952158. Inclusion in this directory is not an endorsement.