Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia
NCT ID: NCT05937126
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1203 participants
OBSERVATIONAL
2020-09-15
2022-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Culture and antimicrobial susceptibility testing
Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.
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
FilmArray Pneumonia Panel
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.
Culture and antimicrobial susceptibility testing
Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.
Interventions
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FilmArray Pneumonia Panel
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.
Culture and antimicrobial susceptibility testing
Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Robin Patel
Principal Investigator
Principal Investigators
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Robin Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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References
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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.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-012521
Identifier Type: -
Identifier Source: org_study_id
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