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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Physician-specific Step Wedge

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Critically ill patients with pneumonia will be treated with an antibiotic strategy at the discretion of the treating clinician

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional

Critically ill patients with pneumonia will be treated with an antibiotic strategy based on results from the BioFire Pneumonia Panel

Group Type EXPERIMENTAL

BioFire Pneumonia Panel

Intervention Type DIAGNOSTIC_TEST

Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel

Interventions

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BioFire Pneumonia Panel

Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No