Back to resultsUse of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia (BioFire)
Primary Purpose
Community-acquired Pneumonia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioFire Pneumonia Panel
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
Meets one of the following:
- Have or plan to obtain a bronchoalveolar lavage (BAL)
- Have or plan to obtain a quantitative endotracheal aspirate sample
- Have already produced a high-quality sputum sample if not intubated
- Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT
Exclusion Criteria:
- Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
- Neutropenic fever, defined as absolute neutrophil count <1000/mm3 and absence of infiltrate on available chest imaging
- Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
- Patient/surrogate refusal
- Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Interventional
Arm Description
Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician
Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel
Outcomes
Primary Outcome Measures
Narrow-spectrum Antibiotic Treatment
A quantitative tool that reflects how broad or narrow antibiotic is
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04781829
Brief Title
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Acronym
BioFire
Official Title
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
COVID pandemic precluded trial initiation. No longer clinical equipoise
Study Start Date
January 15, 2020 (Anticipated)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Physician-specific Step Wedge
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel
Intervention Type
Diagnostic Test
Intervention Name(s)
BioFire Pneumonia Panel
Intervention Description
Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel
Primary Outcome Measure Information:
Title
Narrow-spectrum Antibiotic Treatment
Description
A quantitative tool that reflects how broad or narrow antibiotic is
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
Meets one of the following:
Have or plan to obtain a bronchoalveolar lavage (BAL)
Have or plan to obtain a quantitative endotracheal aspirate sample
Have already produced a high-quality sputum sample if not intubated
Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT
Exclusion Criteria:
Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
Neutropenic fever, defined as absolute neutrophil count <1000/mm3 and absence of infiltrate on available chest imaging
Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
Patient/surrogate refusal
Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia
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