Expanding Antimicrobial Stewardship

Infection Clinical Trial

Official title:

Expanding Antimicrobial Stewardship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746888
• Other study ID #: 2011H0165
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: November 6, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
United States	Wexner Medical Center at The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Caterino

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of infection while in the Emergency Department		participants will be followed for the duration of hospital stay, an expected average of 4 days.	No