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

Not Applicable

Withdrawn

• Conditions: Community-acquired Pneumonia
• Interventions: Diagnostic Test: BioFire Pneumonia Panel

• Registration Number: NCT04781829
• Lead Sponsor: Northwestern University

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-02-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Narrow-spectrum Antibiotic Treatment	14 days	A quantitative tool that reflects how broad or narrow antibiotic is