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

NCT04781829 | Withdrawn DMC

• 1 other identifier: STU00210610
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Narrow-spectrum Antibiotic Treatment

  A quantitative tool that reflects how broad or narrow antibiotic is

  14 days

Study Arms (2)

Control

NO INTERVENTION

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

Interventional

EXPERIMENTAL

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

Interventions

BioFire Pneumonia Panel DIAGNOSTIC_TEST

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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older with known or suspected community-acquired pneumonia who are admitted to the MICU Service
• Meets one of the following:
• Have or plan to obtain a bronchoalveolar lavage (BAL)
• Have or plan to obtain a quantitative endotracheal aspirate sample
• Have already produced a high-quality sputum sample if not intubated
• Primary MICU attending and fellow willing to base antibiotic therapy on results of RDT

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Pulmonary and Critical Care

Model Details: Physician-specific Step Wedge

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: January 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: February 15, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share