Lower Respiratory Tract Infections
Conditions
Brief summary
The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.
Interventions
DIAGNOSTIC_TESTFilmArray 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.
DIAGNOSTIC_TESTCulture and antimicrobial susceptibility testing
Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time until first modification of antibiotic therapy | 96 hours | Mean time until first modification of antibiotic therapy (in hours) |
Countries
United States
Outcome results
None listed