Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781829
Status:
WITHDRAWN
Last Update Posted:
2021-03-04
First Post:
2021-03-01
Brief Title:
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID pandemic precluded trial initiation No longer clinical equipoise
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioFire
Brief Summary:
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia SCAP We hypothesize that when results from a rapid diagnostic test RDT are used to guide antibiotic therapy broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events
Detailed Description:
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia SCAP We hypothesize that when results from a rapid diagnostic test RDT are used to guide antibiotic therapy broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events
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