This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Cefepime-taniborbactam administered 2.5g q8h intravenously (IV) over a 4-hour period for 7 days to 14 days at the investigator's discretion. Dose adjustments for renal function may apply.
Meropenem will be administered 2g q8h IV over 4 hours for 7 days to 14 days at the investigator's discretion. Dose adjustments for renal function may apply.
ACM through Study Day 14
The primary endpoint is ACM, a binary variable, through Study Day 14. The primary endpoint is evaluated in the ITT population and is based on the patient's survival status through Study Day 14.
Time frame: Evaluated on Day 15
ACM through Study Day 28
ACM through Study Day 28; analyzed in ITT and MITT analysis populations.
Time frame: Evaluated on Day 29-33
Safety Outcomes
Safety assessments include the incidence of TEAEs and SAEs, and discontinuation of study drug due to TEAEs.
Time frame: From first dose up to Day 33
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