Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

NCT05937126 | Completed

• 1 other identifier: 19-012521
• Study Type: observational
• Target: 1,203
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Time until first modification of antibiotic therapy

  Mean time until first modification of antibiotic therapy (in hours)

  96 hours

Study Arms (2)

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 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: FilmArray Pneumonia Panel; Diagnostic Test: Culture and antimicrobial susceptibility testing

Interventions

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.

Standard culture and AST PLUS rapid identification and AST

Culture and antimicrobial susceptibility testing DIAGNOSTIC_TEST

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; Standard culture and antimicrobial susceptibility testing (AST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 39426396 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Robin Patel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: September 15, 2020
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)