Use of a Rapid Diagnostic Test for Antibiotic De-escalation in Severe Community Acquired Pneumonia (BioFire)

March 1, 2021 updated by: Richard Wunderink, Northwestern University
The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to conduct an open-label step-wedge pilot clinical trial to compare an antibiotic strategy based on routine use of a novel rapid diagnostic test to usual care in critically ill adults with severe community acquired pneumonia (SCAP). We hypothesize that when results from a rapid diagnostic test (RDT) are used to guide antibiotic therapy, broad-spectrum antibiotic exposure will be reduced in critically ill patients with SCAP without an increase in adverse events.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service

  2. Meets one of the following:

    1. Have or plan to obtain a bronchoalveolar lavage (BAL)
    2. Have or plan to obtain a quantitative endotracheal aspirate sample
    3. Have already produced a high-quality sputum sample if not intubated
  3. Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT

Exclusion Criteria:

  1. Subjects with confirmed extrapulmonary infection requiring antibiotics outside the usual treatment for SCAP, with the exception of suspected uncomplicated urinary tract infection
  2. Neutropenic fever, defined as absolute neutrophil count <1000/mm3 and absence of infiltrate on available chest imaging
  3. Chronic airway infection, defined as cystic fibrosis, lung transplant, or non-CF bronchiectasis
  4. Patient/surrogate refusal
  5. Inability to perform BAL, NBBAL, quantitative ETA, or produce a high-quality sputum sample prior to 48 hours from hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician
Experimental: Interventional
Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel
Diagnostic test: BioFire Pneumonia Panel
Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narrow-spectrum Antibiotic Treatment
Time Frame: 14 days
A quantitative tool that reflects how broad or narrow antibiotic is
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2020

Primary Completion (Anticipated)

January 15, 2021

Study Completion (Anticipated)

February 15, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00210610

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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