Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

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

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

Study Overview

• Status: Completed
• Conditions: Lower Respiratory Tract Infections
• Intervention / Treatment: Diagnostic test: Culture and antimicrobial susceptibility testing; Diagnostic test: FilmArray Pneumonia Panel

• Study Type: Observational
• Enrollment (Actual): 1203

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lower respirator tract samples obtained from inpatient settings only (medical/surgical floors and intensive care units) at Mayo Clinic in Rochester, MN.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Diagnostic test: 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	Diagnostic test: Culture and antimicrobial susceptibility testing; Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Robin Patel, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): September 19, 2022
• Study Completion (Actual): September 19, 2022

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Respiratory Tract Infections; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 19-012521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No