Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli
NCT ID: NCT04574596
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2020-11-12
2021-06-01
Brief Summary
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Detailed Description
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The trigger for enrollment in the study will be the identification in a participating local microbiology laboratory of a 3GCR-Ec in a monomicrobial blood culture. These will be reported to study personnel at the study site, who will evaluate eligibility. If the subject is deemed eligible, the 3GCR-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate also saved at the local laboratory. Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study. The local microbiology laboratory, or designee, will then identify the next subject available with a 3GCS-Ec in a blood culture. These will also be reported to study personnel for evaluation of eligibility as a control. If the control subject is eligible, the corresponding 3GCS-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate will also be saved at the local laboratory . Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study.
For cases and controls, clinical data will be collected from the electronic health records (EHR) for up to 30 days after the index blood culture. Data collection will be performed by study personnel at the site into a central, secure, research database.
One E. coli isolate per study subject will be collected from the index blood culture. No other biologic samples will be collected. Data will be entered at or after the 30-day time point. There will be no long-term follow-up for subjects.
Primary Objective:
To evaluate the use of oral step down therapy in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
Secondary Objectives
1. To describe the treatment regimens used in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
2. To determine the association between duration of intravenous antibiotics and Inverse Probability Weighting (IPW)-adjusted Desirability Of Outcome Ranking (DOOR) outcomes at 30 days
3. To determine the association between total duration of antibiotics and IPW-adjusted DOOR outcomes at 30 days
4. To determine risk factors on days 0, 3, 5, and 7 after first positive blood culture for poor outcomes (either DOOR composite score or individual outcomes) at 30 days.
Exploratory Objective:
• To describe phenotypic and genotypic characteristics of bacterial isolates.
This study is minimal risk to study participants, and has no data safety monitoring board.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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3GCR ceftriaxone-resistant-E. coli
Positive blood culture for above resistant e coli. Observational there will be no intervention
no Intervention
This is an observational study. There is no intervention
3GCS ceftriaxone-susceptible-E. coli
Positive blood culture for above susceptible e coli. Observational there will be no intervention
no Intervention
This is an observational study. There is no intervention
Interventions
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no Intervention
This is an observational study. There is no intervention
Eligibility Criteria
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Inclusion Criteria
2. Hospitalized at the time of obtaining index blood culture OR in the emergency department at the time of obtaining index blood culture, if followed by hospitalization within 72 hours
Exclusion Criteria
2. Previous blood culture positive for E. coli during the current hospitalization
3. In vitro non-susceptibility to any carbapenem tested in the local clinical microbiology laboratory
4. Evidence of carbapenemase production in the E. coli isolate of interest as determined by the local clinical microbiology laboratory
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Vance G. Fowler, MD
Role: STUDY_DIRECTOR
Duke Clinical Research Institute
David van Duin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Harbor-University of California Los Angeles Medical Center
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Weill Cornell Medical College
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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Pro00106280
Identifier Type: -
Identifier Source: org_study_id
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