Table 2. Open in new tab All-Cause...

	Cefiderocol (N = 101)	BAT (N = 49)
Age group
<65 years	10/37 (27.0)	3/27 (11.1)	15.9	−2.7 to 34.5
≥65 years	24/64 (37.5)	7/22 (31.8)	5.7	−17.1 to 28.5
≥75 years	13/29 (44.8)	4/14 (28.6)	16.3	−13.5 to 46.0
Gender
Male	23/66 (34.8)	8/35 (22.9)	12.0	−6.1 to 30.0
Female	11/35 (31.4)	2/14 (14.3)	17.1	−6.8 to 41.1
Race
White	18/63 (28.6)	7/32 (21.9)	6.7	−11.5 to 24.9
Asian	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Other	2/9 (22.2)	0/3 (0.0)	22.2
Region
North America	0/6 (0.0)	0/3 (0.0)	0.0
South America	1/9 (11.1)	0/4 (0.0)	11.1
Europe	19/57 (33.3)	7/28 (25.0)	8.3	−11.8 to 28.5
Asia-Pacific	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Clinical diagnosis
HABP/VABP/HCABP	19/45 (42.2)	4/22 (18.2)	24.0	2.4 to 45.7
BSI/Sepsis	11/30 (36.7)	4/17 (23.5)	13.1	−13.4 to 39.7
cUTI	4/26 (15.4)	2/10 (20.0)	−4.6	−33.0 to 23.8
Baseline pathogen
A. baumannii	19/39 (48.7)	4/17 (23.5)	25.2	−.4 to 50.7
K. pneumoniae	8/34 (23.5)	4/16 (25.0)	−1.5	−27.0 to 24.1
P. aeruginosa	6/17 (35.3)	2/12 (16.7)	18.6	−12.4 to 49.6
S. maltophilia	4/5 (80.0)	0/0
APACHE II score
≤15	13/55 (23.6)	5/27 (18.5)	5.1	−13.3 to 23.6
≥16	21/46 (45.7)	5/22 (22.7)	22.9	.3 to 45.6
Creatinine clearance (mL/min) group
<30 (severe)	8/20 (40.0)	2/7 (28.6)	11.4
30 to 50 (moderate)	10/23 (43.5)	2/8 (25.0)	18.5
>50 to 80 (mild)	9/20 (45.0)	3/12 (25.0)	20.0	−12.8 to 52.8
>80 to <120 (normal)	4/18 (22.2)	1/10 (10.0)	12.2	−14.5 to 39.0
≥120 (ARC)	3/20 (15.0)	2/12 (16.7)	−1.7	−27.9 to 24.6
Bacteremia status^a
Bacteremia	10/24 (41.7)	4/13 (30.8)	10.9	−21.0 to 42.8
No bacteremia	22/62 (35.5)	5/31 (16.1)	19.4	1.8 to 36.9

Cefiderocol (N = 101)

BAT (N = 49)

n/N (%)

Difference (%)

95% CI

Age group

<65 years

10/37 (27.0)

3/27 (11.1)

15.9

−2.7 to 34.5

≥65 years

24/64 (37.5)

7/22 (31.8)

5.7

−17.1 to 28.5

≥75 years

13/29 (44.8)

4/14 (28.6)

16.3

−13.5 to 46.0

Gender

Male

23/66 (34.8)

8/35 (22.9)

12.0

−6.1 to 30.0

Female

11/35 (31.4)

2/14 (14.3)

17.1

−6.8 to 41.1

Race

White

18/63 (28.6)

7/32 (21.9)

6.7

−11.5 to 24.9

Asian

14/29 (48.3)

3/14 (21.4)

26.8

−1.3 to 55.0

Other

2/9 (22.2)

0/3 (0.0)

22.2

Region

North America

0/6 (0.0)

0/3 (0.0)

0.0

South America

1/9 (11.1)

0/4 (0.0)

11.1

Europe

19/57 (33.3)

7/28 (25.0)

8.3

−11.8 to 28.5

Asia-Pacific

14/29 (48.3)

3/14 (21.4)

26.8

−1.3 to 55.0

Clinical diagnosis

HABP/VABP/HCABP

19/45 (42.2)

4/22 (18.2)

24.0

2.4 to 45.7

BSI/Sepsis

11/30 (36.7)

4/17 (23.5)

13.1

−13.4 to 39.7

cUTI

4/26 (15.4)

2/10 (20.0)

−4.6

−33.0 to 23.8

Baseline pathogen

A. baumannii

19/39 (48.7)

4/17 (23.5)

25.2

−.4 to 50.7

K. pneumoniae

8/34 (23.5)

4/16 (25.0)

−1.5

−27.0 to 24.1

P. aeruginosa

6/17 (35.3)

2/12 (16.7)

18.6

−12.4 to 49.6

S. maltophilia

4/5 (80.0)

0/0

APACHE II score

≤15

13/55 (23.6)

5/27 (18.5)

5.1

−13.3 to 23.6

≥16

21/46 (45.7)

5/22 (22.7)

22.9

.3 to 45.6

Creatinine clearance (mL/min) group

<30 (severe)

8/20 (40.0)

2/7 (28.6)

11.4

30 to 50 (moderate)

10/23 (43.5)

2/8 (25.0)

18.5

>50 to 80 (mild)

9/20 (45.0)

3/12 (25.0)

20.0

−12.8 to 52.8

>80 to <120 (normal)

4/18 (22.2)

1/10 (10.0)

12.2

−14.5 to 39.0

≥120 (ARC)

3/20 (15.0)

2/12 (16.7)

−1.7

−27.9 to 24.6

Bacteremia status^a

Bacteremia

10/24 (41.7)

4/13 (30.8)

10.9

−21.0 to 42.8

No bacteremia

22/62 (35.5)

5/31 (16.1)

19.4

1.8 to 36.9

	Cefiderocol (N = 101)	BAT (N = 49)
Age group
<65 years	10/37 (27.0)	3/27 (11.1)	15.9	−2.7 to 34.5
≥65 years	24/64 (37.5)	7/22 (31.8)	5.7	−17.1 to 28.5
≥75 years	13/29 (44.8)	4/14 (28.6)	16.3	−13.5 to 46.0
Gender
Male	23/66 (34.8)	8/35 (22.9)	12.0	−6.1 to 30.0
Female	11/35 (31.4)	2/14 (14.3)	17.1	−6.8 to 41.1
Race
White	18/63 (28.6)	7/32 (21.9)	6.7	−11.5 to 24.9
Asian	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Other	2/9 (22.2)	0/3 (0.0)	22.2
Region
North America	0/6 (0.0)	0/3 (0.0)	0.0
South America	1/9 (11.1)	0/4 (0.0)	11.1
Europe	19/57 (33.3)	7/28 (25.0)	8.3	−11.8 to 28.5
Asia-Pacific	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Clinical diagnosis
HABP/VABP/HCABP	19/45 (42.2)	4/22 (18.2)	24.0	2.4 to 45.7
BSI/Sepsis	11/30 (36.7)	4/17 (23.5)	13.1	−13.4 to 39.7
cUTI	4/26 (15.4)	2/10 (20.0)	−4.6	−33.0 to 23.8
Baseline pathogen
A. baumannii	19/39 (48.7)	4/17 (23.5)	25.2	−.4 to 50.7
K. pneumoniae	8/34 (23.5)	4/16 (25.0)	−1.5	−27.0 to 24.1
P. aeruginosa	6/17 (35.3)	2/12 (16.7)	18.6	−12.4 to 49.6
S. maltophilia	4/5 (80.0)	0/0
APACHE II score
≤15	13/55 (23.6)	5/27 (18.5)	5.1	−13.3 to 23.6
≥16	21/46 (45.7)	5/22 (22.7)	22.9	.3 to 45.6
Creatinine clearance (mL/min) group
<30 (severe)	8/20 (40.0)	2/7 (28.6)	11.4
30 to 50 (moderate)	10/23 (43.5)	2/8 (25.0)	18.5
>50 to 80 (mild)	9/20 (45.0)	3/12 (25.0)	20.0	−12.8 to 52.8
>80 to <120 (normal)	4/18 (22.2)	1/10 (10.0)	12.2	−14.5 to 39.0
≥120 (ARC)	3/20 (15.0)	2/12 (16.7)	−1.7	−27.9 to 24.6
Bacteremia status^a
Bacteremia	10/24 (41.7)	4/13 (30.8)	10.9	−21.0 to 42.8
No bacteremia	22/62 (35.5)	5/31 (16.1)	19.4	1.8 to 36.9

Table 2.

Open in new tab

All-Cause Mortality at Day 49 by Baseline Subgroup, CREDIBLE-CR Trial

	Cefiderocol (N = 101)	BAT (N = 49)
	n/N (%)	n/N (%)	Difference (%)	95% CI
Age group
<65 years	10/37 (27.0)	3/27 (11.1)	15.9	−2.7 to 34.5
≥65 years	24/64 (37.5)	7/22 (31.8)	5.7	−17.1 to 28.5
≥75 years	13/29 (44.8)	4/14 (28.6)	16.3	−13.5 to 46.0
Gender
Male	23/66 (34.8)	8/35 (22.9)	12.0	−6.1 to 30.0
Female	11/35 (31.4)	2/14 (14.3)	17.1	−6.8 to 41.1
Race
White	18/63 (28.6)	7/32 (21.9)	6.7	−11.5 to 24.9
Asian	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Other	2/9 (22.2)	0/3 (0.0)	22.2
Region
North America	0/6 (0.0)	0/3 (0.0)	0.0
South America	1/9 (11.1)	0/4 (0.0)	11.1
Europe	19/57 (33.3)	7/28 (25.0)	8.3	−11.8 to 28.5
Asia-Pacific	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Clinical diagnosis
HABP/VABP/HCABP	19/45 (42.2)	4/22 (18.2)	24.0	2.4 to 45.7
BSI/Sepsis	11/30 (36.7)	4/17 (23.5)	13.1	−13.4 to 39.7
cUTI	4/26 (15.4)	2/10 (20.0)	−4.6	−33.0 to 23.8
Baseline pathogen
A. baumannii	19/39 (48.7)	4/17 (23.5)	25.2	−.4 to 50.7
K. pneumoniae	8/34 (23.5)	4/16 (25.0)	−1.5	−27.0 to 24.1
P. aeruginosa	6/17 (35.3)	2/12 (16.7)	18.6	−12.4 to 49.6
S. maltophilia	4/5 (80.0)	0/0
APACHE II score
≤15	13/55 (23.6)	5/27 (18.5)	5.1	−13.3 to 23.6
≥16	21/46 (45.7)	5/22 (22.7)	22.9	.3 to 45.6
Creatinine clearance (mL/min) group
<30 (severe)	8/20 (40.0)	2/7 (28.6)	11.4
30 to 50 (moderate)	10/23 (43.5)	2/8 (25.0)	18.5
>50 to 80 (mild)	9/20 (45.0)	3/12 (25.0)	20.0	−12.8 to 52.8
>80 to <120 (normal)	4/18 (22.2)	1/10 (10.0)	12.2	−14.5 to 39.0
≥120 (ARC)	3/20 (15.0)	2/12 (16.7)	−1.7	−27.9 to 24.6
Bacteremia status^a
Bacteremia	10/24 (41.7)	4/13 (30.8)	10.9	−21.0 to 42.8
No bacteremia	22/62 (35.5)	5/31 (16.1)	19.4	1.8 to 36.9

	Cefiderocol (N = 101)	BAT (N = 49)
	n/N (%)	n/N (%)	Difference (%)	95% CI
Age group
<65 years	10/37 (27.0)	3/27 (11.1)	15.9	−2.7 to 34.5
≥65 years	24/64 (37.5)	7/22 (31.8)	5.7	−17.1 to 28.5
≥75 years	13/29 (44.8)	4/14 (28.6)	16.3	−13.5 to 46.0
Gender
Male	23/66 (34.8)	8/35 (22.9)	12.0	−6.1 to 30.0
Female	11/35 (31.4)	2/14 (14.3)	17.1	−6.8 to 41.1
Race
White	18/63 (28.6)	7/32 (21.9)	6.7	−11.5 to 24.9
Asian	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Other	2/9 (22.2)	0/3 (0.0)	22.2
Region
North America	0/6 (0.0)	0/3 (0.0)	0.0
South America	1/9 (11.1)	0/4 (0.0)	11.1
Europe	19/57 (33.3)	7/28 (25.0)	8.3	−11.8 to 28.5
Asia-Pacific	14/29 (48.3)	3/14 (21.4)	26.8	−1.3 to 55.0
Clinical diagnosis
HABP/VABP/HCABP	19/45 (42.2)	4/22 (18.2)	24.0	2.4 to 45.7
BSI/Sepsis	11/30 (36.7)	4/17 (23.5)	13.1	−13.4 to 39.7
cUTI	4/26 (15.4)	2/10 (20.0)	−4.6	−33.0 to 23.8
Baseline pathogen
A. baumannii	19/39 (48.7)	4/17 (23.5)	25.2	−.4 to 50.7
K. pneumoniae	8/34 (23.5)	4/16 (25.0)	−1.5	−27.0 to 24.1
P. aeruginosa	6/17 (35.3)	2/12 (16.7)	18.6	−12.4 to 49.6
S. maltophilia	4/5 (80.0)	0/0
APACHE II score
≤15	13/55 (23.6)	5/27 (18.5)	5.1	−13.3 to 23.6
≥16	21/46 (45.7)	5/22 (22.7)	22.9	.3 to 45.6
Creatinine clearance (mL/min) group
<30 (severe)	8/20 (40.0)	2/7 (28.6)	11.4
30 to 50 (moderate)	10/23 (43.5)	2/8 (25.0)	18.5
>50 to 80 (mild)	9/20 (45.0)	3/12 (25.0)	20.0	−12.8 to 52.8
>80 to <120 (normal)	4/18 (22.2)	1/10 (10.0)	12.2	−14.5 to 39.0
≥120 (ARC)	3/20 (15.0)	2/12 (16.7)	−1.7	−27.9 to 24.6
Bacteremia status^a
Bacteremia	10/24 (41.7)	4/13 (30.8)	10.9	−21.0 to 42.8
No bacteremia	22/62 (35.5)	5/31 (16.1)	19.4	1.8 to 36.9

Abbreviations: APACHE II, APACHE, Acute Physiology and Chronic Health Evaluation II; ARC, augmented renal clearance; BAT, best available therapy; BSI, bloodstream infections; CI, confidence interval; cUTI, complicated urinary tract infections; HCABP/VABP/HCABP, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia/healthcare-associated bacterial pneumonia; SOFA, sequential organ failure assessment.

^aPrimary or concomitant bacteremia in any clinical diagnosis subgroup. Bacteremia subgroups defined within the CR mITT Population rather than the safety population.

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