Table 3.

Design of randomized, multinational cefiderocol trials in hospitalized adults with aerobic Gram-negative bacterial infections

	APEKS-cUTI [74]	APEKS-NP [75]	CREDIBLE-CR [76]
Design	Double-blind, noninferiority, phase 2, US FDA-approved design	Double-blind, noninferiority, phase 3, US FDA-approved design	Open-label, pathogen-focused, descriptive, phase 3, EMA-approved design
Treatmentsa	Cefiderocol 2 g q8h 1-h infusion or imipenem/cilastatin 1 g q8h infusion	Cefiderocol 2 g q8h 3-h infusion or meropenem 2 g q8h 3-h infusionb	Cefiderocolc 2 g q8h 3-h infusion or best available therapyd

BSI bloodstream infection, cUTI complicated urinary tract infection, HAP hospital-acquired pneumonia, HCAP healthcare-associated pneumonia, pts patients, q8h every 8 h, VAP ventilator-associated pneumonia

^aAdministered for 7–14 days (could be extended up to 21 days in APEKS-NP and CREDIBLE-CR). Dosages adjusted for kidney function; ^bBoth groups received open-label intravenous linezolid for Gram-positive bacteria and/or methicillin-resistant Staphylococcus aureus coverage; ^cOne adjunctive agent (excluding polymyxins, cephalosporins and carbapenems) was permitted in pts with pneumonia or BSI/sepsis; ^dA maximum of three prespecified antibacterials, dosed as per the country’s label