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OpenTrials
Completed

NCT Number: NCT05937126

Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia

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

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Key information

Conditions

Lower Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Culture and antimicrobial susceptibility testing

Diagnostic Test

Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.

Primary outcomes

  1. Time until first modification of antibiotic therapy

    Time frame: 96 hours

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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