- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746888
Expanding Antimicrobial Stewardship
November 6, 2013 updated by: Jeffrey Caterino
Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist.
These patients often have atypical presentations which can complicate diagnosis and treatment.
The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing.
This research study involves data collection from enrolled subjects and treating physicians.
The data will be collected using a patient interview which will be answered directly by the patient or caregiver.
Additional surveys will be administered to the Emergency Department treating physician and subsequent physician.
Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department.
A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
437
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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Ohio
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Columbus, Ohio, United States, 43210
- Wexner Medical Center at the Ohio State University
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults 65 years of age and older who present to the Emergency Department.
Description
Inclusion Criteria:
- 65 years of age
Exclusion Criteria:
- Patient incarcerated
- Chief complaint of suicidal or homicidal ideation
- Patient primarily evaluated by the trauma team
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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Older Adults
Adults 65 years and older who present to the Emergency Department.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of infection while in the Emergency Department
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days.
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participants will be followed for the duration of hospital stay, an expected average of 4 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey M Caterino, MD, MPH, Ohio State University
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
August 1, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
October 23, 2012
First Submitted That Met QC Criteria
December 7, 2012
First Posted (Estimate)
December 11, 2012
Study Record Updates
Last Update Posted (Estimate)
November 8, 2013
Last Update Submitted That Met QC Criteria
November 6, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2011H0165
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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