Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

Mayo Clinic

Status: Completed

Conditions: Lower Respiratory Tract Infections

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

Study type: Observational

Funder types: Other

Identifiers

NCT05937126

19-012521

Details and patient eligibility

About

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

Enrollment: 1,203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,203 participants in 2 patient groups

Standard culture and antimicrobial susceptibility testing (AST)

Description:

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).

Treatment:

Diagnostic Test: Culture and antimicrobial susceptibility testing

Standard culture and AST PLUS rapid identification and AST

Description:

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

Treatment:

Diagnostic Test: Culture and antimicrobial susceptibility testing

Diagnostic Test: FilmArray Pneumonia Panel