Ignite Creation Date:
2024-05-06 @ 6:08 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05568654
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2022-10-03
Brief Title:
Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures To accomplish this we will perform a 3-year pragmatic multicenter 2 X 2 factorial cluster randomized controlled trial with four arms a rapid diagnostic testing b pharmacist-led de-escalation c rapid diagnostic testing pharmacist-led de-escalation and d usual care
Detailed Description:
Community-acquired pneumonia CAP is a leading cause of hospitalization and inpatient antimicrobial use in the United States However diagnostic uncertainty at the time of initial treatment and following negative cultures is associated with prolonged exposure to broad-spectrum antimicrobials We propose a large multicenter cluster randomized controlled trial to test two approaches to reducing the use of broad-spectrum antibiotics in adult patients with CAP a routine use of rapid diagnostic testing at the time of admission and b pharmacist -led de-escalation after 48 hours for clinically stable patients with negative cultures
When a patient is admitted with a diagnosis of pneumonia it will trigger the admission order set and if the physician is in a hospital randomized to the rapid diagnostic testing arm a CDSS-based alert will be generated in real time and the form will append orders for viral and UAT testing For physicians at a hospital randomized to the control condition ordering will proceed as usual standard-of-care A second CDSS algorithm will identify study patients who have negative culture results blood andor sputum for greater than 48 hours and generate a list for the antimicrobial stewardship pharmacist who will be a member of the study team The alerts will be audited by the clinical pharmacist daily on weekdays at a centralized location In clinically stable patients from hospitals randomized to the de-escalation arm the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call Epic chat or page The primary outcome will be the duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy from initiation to discontinuation Secondary outcomes will include detection of influenzaRSV de-escalation and re-escalation to broad-spectrum antibiotics after de-escalation total antibiotic duration in-hospital mortality ICU transfer after admission healthcare-associated CDI and acute kidney injury after 48 hours
When a patient is admitted with a diagnosis of pneumonia it will trigger the admission order set and if the physician is in a hospital randomized to the rapid diagnostic testing arm a CDSS-based alert will be generated in real time and the form will append orders for viral and UAT testing For physicians at a hospital randomized to the control condition ordering will proceed as usual standard-of-care A second CDSS algorithm will identify study patients who have negative culture results blood andor sputum for greater than 48 hours and generate a list for the antimicrobial stewardship pharmacist who will be a member of the study team The alerts will be audited by the clinical pharmacist daily on weekdays at a centralized location In clinically stable patients from hospitals randomized to the de-escalation arm the pharmacist will communicate their recommendations for de-escalation to the clinical providers via a phone call Epic chat or page The primary outcome will be the duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy from initiation to discontinuation Secondary outcomes will include detection of influenzaRSV de-escalation and re-escalation to broad-spectrum antibiotics after de-escalation total antibiotic duration in-hospital mortality ICU transfer after admission healthcare-associated CDI and acute kidney injury after 48 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None