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

Community-acquired Pneumonia Clinical Trial

— BioFire  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04781829
• Other study ID #: STU00210610
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: March 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narrow-spectrum Antibiotic Treatment	A quantitative tool that reflects how broad or narrow antibiotic is	14 days