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The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard culture and antimicrobial susceptibility testing (AST) | 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). |
| |
| Standard culture and AST PLUS rapid identification and AST | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FilmArray Pneumonia Panel | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time until first modification of antibiotic therapy | Mean time until first modification of antibiotic therapy (in hours) | 96 hours |
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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:
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Lower respirator tract samples obtained from inpatient settings only (medical/surgical floors and intensive care units) at Mayo Clinic in Rochester, MN.
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| Name | Affiliation | Role |
|---|---|---|
| Robin Patel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39426396 | Derived | Virk A, Strasburg AP, Kies KD, Donadio AD, Mandrekar J, Harmsen WS, Stevens RW, Estes LL, Tande AJ, Challener DW, Osmon DR, Fida M, Vergidis P, Suh GA, Wilson JW, Rajapakse NS, Borah BJ, Dholakia R, Reed KA, Hines LM, Schuetz AN, Patel R. Rapid multiplex PCR panel for pneumonia in hospitalised patients with suspected pneumonia in the USA: a single-centre, open-label, pragmatic, randomised controlled trial. Lancet Microbe. 2024 Dec;5(12):100928. doi: 10.1016/S2666-5247(24)00170-8. Epub 2024 Oct 17. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Culture and antimicrobial susceptibility testing | Diagnostic Test | Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice. |
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