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NCT05937126 Clinical Trial

Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

Lower Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05937126
Other study ID # 19-012521
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date September 19, 2022

Study information
Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1203
Est. completion date September 19, 2022
Est. primary completion date September 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time until first modification of antibiotic therapy Mean time until first modification of antibiotic therapy (in hours) 96 hours
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