- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018434
The Epidemiology of Infection With Vancomycin-Resistant Enterococci
June 25, 2015 updated by: US Department of Veterans Affairs
Current projects study veteran patients with chronic ulcers and MRSA colonization and infection, patients with imipenem-resistant P. aeruginosa colonization and infection, the relationships between staffing pattern, severity of illness and nosocomial infections in intensive care units and infection control practices for veteran patients with suspected tuberculosis.
Study Overview
Status
Completed
Conditions
Detailed Description
Nosocomial infections are often caused by antimicrobial-resistant pathogens such as vancomycin resistant enterococci (VRE) and are a major cause increased morbidity, mortality and cost in hospitalized patients.
Nosocomial bloodstream infections (BSI) add 7 to 21 days to the length of stay and cost institutions $3,061 to $40,000.
The average cost of treating patients with VRE BSI has been estimated as 30% more than vancomycin sensitive enterococcal BSI.
In addition, the attributable mortality of VRE BSI has been estimated as 37%.
Preventing VRE infection and VRE transmission is clearly important and understanding the risk factors for each is a necessary first step.
The goal of this three year study is to identify potentially effective interventions for the prevention of VRE infection and colonization Before testing interventions, we need to identify risk factors for VRE infection which will allow us to (1) identify potentially effective interventions and (2) focus on patients at highest risk for VRE infection.
We will study the effect of antibiotic use, particularly vancomycin, and impaired host defenses on VRE infection in a large cohort study of VRE colonized patients.
The goal is to develop a statistical model, which will allow us to identify alterable risk factors, which could reduce the risk of VRE infection.
Many case-control studies have been performed to study VRE colonization and infection; however, most of these studies were small with insufficient sample sizes for multivariate modeling.
Vancomycin-resistant enterococci (VRE) can be transmitted from patient to patient.
We propose to model the ecological relationship between the rate of VRE transmission and the pre-existing prevalence of VRE in an ICU to determine whether the relationship is linear or exponential.
The objective is to determine at what point the rate of transmission increases significantly that specific interventions should occur (e.g.
reverse isolation of all patients, close unit to new admissions).
Controlling health care costs is an important part of health care today and is particularly important in the capitated reimbursement system that VHA is adopting.
Potential interventions to prevent VRE infections and VRE transmission must be cost-effective to the healthcare system to justify their adoption.
The current study will quantify the operational costs associated with VRE colonization and infection in hospitalized patients compared to their non-colonized counterparts.
Patients from the intensive care units with and without VRE colonization will be covaried for severity of illness and stratified by Major Diagnostic Category (by primary ICD-9 code) and marginal health care costs compared.
This estimate can then be used to examine the potential cost-effectiveness of identified interventions, and to justify the system-wide costs of implementing these interventions.
Study Type
Observational
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
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Maryland
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Baltimore, Maryland, United States, 21201
- VA Maryland Health Care System
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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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Patients from the intensive care units with or without VRE colonization.
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
Cohorts and Interventions
Group / Cohort |
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Group 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
July 1, 1998
Study Completion
June 1, 2001
Study Registration Dates
First Submitted
July 3, 2001
First Submitted That Met QC Criteria
July 4, 2001
First Posted (Estimate)
July 5, 2001
Study Record Updates
Last Update Posted (Estimate)
June 26, 2015
Last Update Submitted That Met QC Criteria
June 25, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CADE-RCD2
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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