Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Diagnostic Test: BioFire Pneumonia Panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Physician-specific Step Wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician | |
| Experimental: Interventional<br>Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel | Diagnostic Test: BioFire Pneumonia Panel<br>* Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narrow-spectrum Antibiotic Treatment | A quantitative tool that reflects how broad or narrow antibiotic is | 14 days |