3 results
Approved WMOCompleted
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Approved WMOCompleted
1. To predict the clinical course (in terms of occurrence of ALI and ARDS, duration of mechanical ventilation, need for renal replacement therapy, length of ICU-stay, length of hospital-stay, ICU-mortality, 30-day mortality) in patients after…
Approved WMOCompleted
Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…