Hospital-acquired bacterial pneumonia (HABP), including ventilated HABP (vHABP) and ventilator-associated bacterial pneumonia (VABP) caused by Gram-negative bacteria
Conditions
Brief summary
The primary endpoint is the Day 14 all-cause mortality rate in the MITT population
Detailed description
Day 28 all-cause mortality rate in the MITT population, Day 14 and Day 28 all-cause mortality rate in the micro-MITT, extended micro-MITT, CE, ME, and CR-MITT populations, The proportion of subjects with clinical success as evaluated by the investigator at Day 4, EOT, TOC, and LFU visits in the MITT, micro-MITT, extended micro-MITT, CE, ME, and CR-MITT populations, The proportion of subjects with microbiological success at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, CR-MITT, and ME populations, The proportional of subjects with microbiological success by pathogen at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, ME, and CR-MITT populations, The proportion of subjects with overall success at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, ME, and CR-MITT populations
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Day 14 all-cause mortality rate in the MITT population | — |
Secondary
| Measure | Time frame |
|---|---|
| Day 28 all-cause mortality rate in the MITT population, Day 14 and Day 28 all-cause mortality rate in the micro-MITT, extended micro-MITT, CE, ME, and CR-MITT populations, The proportion of subjects with clinical success as evaluated by the investigator at Day 4, EOT, TOC, and LFU visits in the MITT, micro-MITT, extended micro-MITT, CE, ME, and CR-MITT populations, The proportion of subjects with microbiological success at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, CR-MITT, and ME populations, The proportional of subjects with microbiological success by pathogen at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, ME, and CR-MITT populations, The proportion of subjects with overall success at EOT, TOC, and LFU visits in the micro-MITT, extended micro-MITT, ME, and CR-MITT populations | — |
Countries
France, Spain