SEVERE COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (SCABP)
Conditions
Brief summary
Time (days) to clinical recovery, the day all severity criteria which met the SCABP definition per protocol at randomization, and any new severity criteria which occurred after randomization, are resolved, and no repeat or additional severity criteria are met within 24 hours after recovery, Incidence and severity of TEAEs including infusion-related reactions, Incidence of IMP IV infusion interruptions and discontinuations
Detailed description
Time to critical care management discharge (days), Time to hospital discharge (days), Proportion of subjects who achieve clinical recovery by Day 5, Relative change from baseline in whole SOFA score at Day 7
Interventions
Sponsors
Eagle Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (days) to clinical recovery, the day all severity criteria which met the SCABP definition per protocol at randomization, and any new severity criteria which occurred after randomization, are resolved, and no repeat or additional severity criteria are met within 24 hours after recovery, Incidence and severity of TEAEs including infusion-related reactions, Incidence of IMP IV infusion interruptions and discontinuations | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to critical care management discharge (days), Time to hospital discharge (days), Proportion of subjects who achieve clinical recovery by Day 5, Relative change from baseline in whole SOFA score at Day 7 | — |
Countries
Belgium, Czechia, France, Greece, Hungary, Latvia, Romania, Slovakia, Spain
Outcome results
None listed