Home » Trials » SLCTR/2024/019 » Protocols
Date
2024-11-01
Protocol
Protocol changed
Item Changed
1. Secondary outcome(s)
Previous Version
1.Individual components of the binary clinical outcome in the primary endpoint will be assessed [following are the individual components right?] Diagnosis of lung abscess/ empyema Diagnosis of pneumonia in non-pneumonia LRTI Seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription (at Day 30) Admission to and duration of admission to the intensive care unit (ICU) during index hospitalization Use of and duration of use of supplemental oxygen by nasal cannula or high flow nasal cannula during index hospitalization Duration of non-invasive ventilation during index hospitalization Duration of mechanical ventilation during index hospitalization Duration of index hospitalization Prescription of antibacterials on Day 1, Day 2, Day 3, by discharge, and by Day 30. Prescription of oseltamivir on Day 1, Day 2, Day 3, at discharge, and by Day 30. 11.Total oseltamivir exposure per patient (defined as the total number of days prescribed oseltamivir) during hospitalization and by Day 30. Prescription of SARS-CoV-2 antivirals on Day 1, Day 2, Day 3, at discharge, and by Day 30. [Secondary outcomes 1-3 - At day 30 4-8 -At discharge or Day 30, whichever comes first 9-12 - At day 30 ]; 2.• Physician adherence to the eCDST diagnostic recommendations. [Within 24 hours and 48 hours of receiving recommendations, in the intervention group ]
Next Version
1.Individual components of the binary clinical outcome in the primary endpoint will be assessed 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; 2. Seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription (at Day 30); 3.Admission to and duration of admission to the intensive care unit (ICU) during index hospitalization; 4.Use of and duration of use of supplemental oxygen by nasal cannula or high flow nasal cannula or face mask during index hospitalization; 5.Duration of non-invasive ventilation during index hospitalization; 6.Duration of mechanical ventilation during index hospitalization; 7.Duration of index hospitalization; 8.Prescription of antibacterials on Day 1, Day 2, Day 3, by discharge, and by Day 30; 9.Prescription of oseltamivir on Day 1, Day 2, Day 3, at discharge, and by Day 30; 10.Total oseltamivir exposure per patient (defined as the total number of days prescribed oseltamivir) during hospitalization and by Day 30; 11.Prescription of SARS-CoV-2 antivirals on Day 1, Day 2, Day 3, at discharge, and by Day 30; [Secondary outcomes 1 At day 30 2-7 At discharge or Day 30, whichever comes first 8-11 At day 1,2,3 at discharge, and day30]; 12. Physician adherence to the eCDST diagnostic recommendations. [Within 24 hours and 48 hours of receiving recommendations, in the intervention group]