Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.

Official Title
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Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia (RASP) - A Quality Improvement Theragnostic Stewardship Project

Conditions
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Lower Respiratory Tract Infections

Intervention / Treatment
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* Diagnostic Test: FilmArray Pneumonia Panel
* Diagnostic Test: Culture and antimicrobial susceptibility testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subjects who have the following samples collected and submitted for culture as part of routine clinical practice: Expectorated sputum, induced sputum, tracheal secretions, bronchoalveolar lavage. Exclusion Criteria: Subjects who do not have MN Research Authorization on file Rejected sputum culture (i.e., due to low quality) Positive respiratory cultures within prior 7 days Deceased at time of sample randomization Any subject affected by Global Data protection Regulation (GDPR) Previous enrollment in the study. Outpatient status

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard culture and antimicrobial susceptibility testing (AST)<br>Lower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and antimicrobial susceptibility testing (AST). | Diagnostic Test: Culture and antimicrobial susceptibility testing<br>* Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.<br>|
| Standard culture and AST PLUS rapid identification and AST<br>Lower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and AST PLUS rapid identification and AST using the FDA-approved/cleared FilmArray Pneumonia Panel | Diagnostic Test: FilmArray Pneumonia Panel<br>* FDA-approved/cleared molecular, multiplex device that rapidly identifies viruses, bacteria, and antimicrobial resistance genes in sputum-like and bronchoalveolar lavage (BAL)-like specimens obtained from individuals with signs of a lower respiratory tract infection.<br>Diagnostic Test: Culture and antimicrobial susceptibility testing<br>* Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until first modification of antibiotic therapy | Mean time until first modification of antibiotic therapy (in hours) | 96 hours |