Community-acquired Pneumonia
Conditions
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.
Interventions
DIAGNOSTIC_TESTBioFire Pneumonia Panel
Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Physician-specific Step Wedge
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narrow-spectrum Antibiotic Treatment | 14 days | A quantitative tool that reflects how broad or narrow antibiotic is |
Outcome results
None listed