Table 4.

Efficacy of cefiderocol in patients with Gram-negative bacterial infections in clinical studies

Treatment (no. of ptsa)	ACM at day 14 (% pts) [95% CI]	Clinical cure at TOCb (% pts) [95% CI]	Microbiological eradication at TOCb (% pts) [95% CI]
In pts with complicated urinary tract infection
APEKS-cUTI [74]
Cefiderocol (252)c	ND	90	73
Imipenem/cilastatin (119)	ND	87	56
Treatment difference	ND	2.39 [−4.66 to 9.44]	17.25 [6.92–27.58]
CREDIBLE-CR [76]
Cefiderocol (17)	12 [1.5–36.4]	71 [44.0–89·7]	53d [27.8–77.0]
Best available therapy (5)	40 [5.3–85.3]	60 [14.7–94.7]	20d [0.5–71.6]
In pts with nosocomial pneumonia
APEKS-NP [75]
Cefiderocol (145]	12.4	65	41
Meropenem (147)	11.6	67	42
Treatment difference	0.8* [–6.6 to 8.2]d	–1.8 [–12.7 to 9.0]	–0.8 [–12.1 to 10.5]
CREDIBLE-CR [76]
Cefiderocol (40)	25 [12.7–41.2]	50d [33.8–66.2]	23 [10.8–38.5]
Best available therapy (19)	11 [1.3–43.7]	53d [28.9–75.6]	21 [6.1–45.6]
In pts with bloodstream infection or sepsis (CREDIBLE-CR) [76]
Cefiderocol (23)	22 [7.5–43.7]	43d [23.2–65.5]	30 [13.2–52.9]
Best available therapy (14)	7 [0.2–33.9]	43d [17.7–71.1]	29 [8.4–58.1]
In overall population with CR infections (CREDIBLE-CR) [76]
Cefiderocol (80)	21 [12.9–31.8]	53 [41.0–63.8]	31 [21.3–42.6]
Best available therapy (38)	13 [4.4–28.1]	50 [33.4–66.6]	24 [11.4–40.2]

ACM all-cause mortality, ITT intent-to-treat, ND not determined, pts patients, TOC test of cure

*p = 0.002 for noninferiority (at 12.5% margin) hypothesis

^aPrimary efficacy populations: microbiological ITT in APEKS-cUTI and CREDIBLE-CR, and modified ITT in APEKS-NP; ^b7 ± 2 days after the end of treatment; ^cCefiderocol was noninferior (at 15% margin) to the comparator for the primary endpoint of composite of clinical and microbiological outcomes at TOC (73% vs 55%; treatment difference 18.58%; 95% CI 8.23–28.92; p = 0.0004); ^dPrimary endpoint