A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens
A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.
Inclusion Criteria:
Subjects 18 years or older at the time of signing informed consent
Subjects who have provided written informed consent or their informed consent has been provided by a legally authorized representative
Subjects who meet the clinical diagnosis criteria for hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP)
All subjects must fulfill at least 1 of the following clinical criteria at screening:
All subjects must have at least 1 of the following signs:
All subjects must have a chest radiograph during screening showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia. A computed tomography (CT) scan in the same time window showing the same findings could also be acceptable
All subjects must have a suspected Gram-negative infection involving the lower respiratory tract
Exclusion Criteria:
Ostrava-Poruba, 708 52, Czechia
LaRoche-sur-Yon, 85925, France
Tikva, 49100, Israel
Shimajiri-gun, Okinawa 901-1193, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Saldus Novads, LV-1002, Latvia
Sait-Petersburg, 194354, Russia
Vinnitsya, 21029, Ukraine