Date

2024-11-01

Protocol

Protocol changed

Item Changed

1. Primary outcome(s)

Previous Version

1.Co-primary endpoint consisting of the following two endpoints: 1. Total duration of antibacterial prescription for the index visit (superiority analysis) Total duration of antibacterial prescription for the index visit will include the number of days that antibacterials are prescribed during the index hospitalization, as well as the number of days that antibacterials are prescribed at discharge from the hospital (intended use). A day of antibacterial prescription will be defined as each day a subject is prescribed any oral, intramuscular, or intravenous antibacterial (may be non-consecutive days), excluding anti-virals, anti-fungals, or anti-parasitics. [30 days (after enrollment) or at discharge, whichever comes first ]; 2.Clinical outcomes by Day 30 (non-inferiority analysis) A binary clinical endpoint consisting of a composite of adverse outcomes that could be attributed to withholding antibacterials. These outcomes would not be present at enrollment, and could occur anytime until Day 30. At least one of the following adverse outcomes should be present to meet this endpoint: · Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness ) · Use of mechanical ventilation (via endotracheal tube) · Readmission to hospital ·Death [Day 1 will be day of enrollment, and participants will be followed through Day 30. [Assessed daily while hospitalized, and then at Day 30] ]

Next Version

Co-primary endpoint consisting of the following two endpoints: 1. Total duration of antibacterial prescription for the index visit (superiority analysis) Total duration of antibacterial prescription for the index visit will include the number of days that antibacterials are prescribed during the index hospitalization, as well as the number of days that antibacterials are prescribed at discharge from the hospital (intended use), for a maximum total of 14 days. A day of antibacterial prescription will be defined as each day a subject is prescribed any oral, intramuscular, or intravenous antibacterial (may be non-consecutive days), excluding anti-virals, anti-fungals, or anti-parasitics [30 days (after enrollment) or at discharge, whichever comes first] 2.Clinical outcomes by Day 30 (non-inferiority analysis) A binary clinical endpoint consisting of a composite of adverse outcomes that could be attributed to withholding antibacterials. These outcomes would not be present at enrollment, and could occur anytime until Day 30. At least one of the following adverse outcomes should be present to meet this endpoint: · Use of non-invasive ventilation (i.e., continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for treatment of the acute illness) · Use of mechanical ventilation (via endotracheal tube) or extracorporeal membrane oxygenation (ECMO) · Readmission to hospital ·Death [Day 1 will be day of enrollment, and participants will be followed through Day 30. [Assessed daily while hospitalized, and then at Day 30] For co-primary endpoint 1, the time of assessment will be 30 days (after enrollment) or at discharge, whichever comes first] For co-primary endpoint 2, the time of assessment with be 30 days (after enrollment).