Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

Completed

• Conditions: Lower Respiratory Tract Infections
• Interventions: Diagnostic Test: FilmArray Pneumonia Panel; Diagnostic Test: Culture and antimicrobial susceptibility testing

• Registration Number: NCT05937126
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-15
• Primary Completion: 2022-09-19
• Study Completion: 2022-09-19
• Status Verified: 2023-06
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1203

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard culture and AST PLUS rapid identification and AST	FilmArray Pneumonia Panel	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
Standard culture and antimicrobial susceptibility testing (AST)	Culture and antimicrobial susceptibility testing	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).
Standard culture and AST PLUS rapid identification and AST	Culture and antimicrobial susceptibility testing	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

Primary Outcome Measures

Name	Time	Method
Time until first modification of antibiotic therapy	96 hours	Mean time until first modification of antibiotic therapy (in hours)

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States