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Table 2 Characteristics of patients in the de-escalation group (intervention) and in the non-de-escalation group (control)

From: Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial

Variables

All (n = 66)

De-escalation (n = 32)

Non-de-escalation (n = 34)

P-value

Baseline characteristics

 Mean age, years

64.8 ± 19.6

67.5 ± 17.2

62.2 ± 21.6

0.28

 Female

38 (57.6%)

19 (59.4%)

19 (55.9%)

0.81

 Medicine ward

58 (87.9%)

26 (81.3%)

32 (94.1%)

0.11

Underlying disease

Hypertension

37 (56.1%)

19 (59.4%)

18 (52.9%)

0.60

Cerebrovascular disease

15 (22.7%)

9 (28.1%)

6 (17.7%)

0.31

Chronic lung disease

10 (15.2%)

2 (6.3%)

8 (23.5%)

0.08

Cardiovascular disease

22 (33.3%)

11 (34.4%)

11 (32.4%)

0.86

Diabetes mellitus

25 (37.9%)

11 (34.4%)

14 (41.2%)

0.57

Chronic kidney disease

23 (34.9%)

12 (37.5%)

11 (32.4%)

0.66

Chronic liver disease

7 (10.6%)

3 (9.4%)

4 (11.8%)

1.00

Malignancy

17 (26.6%)

9 (28.1%)

8 (23.5%)

0.67

Any immunocompromised conditiona

16 (24.2%)

7 (21.9%)

9 (36.5%)

0.66

APACHE II score at enrollmentb

12.4 ± 5.9 (n = 10)

13.8 ± 8.2 (n = 5)

11.0 ± 2.3 (n = 5)

0.49

Modified APACHE II score at enrollmentc

8.9 ± 4.9

8.9 ± 5.1

8.9 ± 4.9

0.94

History of organ insufficiency

35 (53.9%)

20 (62.5%)

15 (45.5%)

0.17

Emergency surgery

8 (12.1%)

5 (15.6%)

3 (8.8%)

0.47

Acute renal failure

8 (12.1%)

8 (25.0%)

0 (0.0%)

0.002

ICU admission

3 (4.6%)

2 (6.3%)

1 (2.9%)

0.42

Characteristics of infections

 Hospital-acquired infection

32 (48.5%)

12 (37.5%)

20 (58.8%)

0.08

Site of infection at enrollment

   

1.00

Urinary tract infection

27 (40.9%)

13 (40.6%)

14 (41.2%)

Pneumonia

11 (16.7%)

5 (15.6%)

6 (16.7%)

Others

29 (43.9%)

14 (43.8%)

15 (44.1%)

   Primary bacteremia

26 (78.8%)

14 (82.4%)

12 (75.0%)

   Skin infection

1 (1.5%)

0

1 (2.9%)

   Reproductive tract infection

1 (1.5%)

0

1 (2.9%)

   Gastrointestinal tract infection

1 (1.5%)

0

1 (2.9%)

Having bacteremia

33 (50.0%)

17 (53.1%)

16 (47.1%)

0.62

Cause of bacteremiad

 

(n = 17)

(n = 16)

0.57

Primary bacteremia

26 (78.8%)

14 (82.4%)

12 (75.0%)

Urinary tract infection

5 (15.2%)

3 (17.6%)

2 (12.5%)

Catheter-related infection

2 (6.0%)

0

2 (12.5%)

Causative pathogene

Escherichia coli

46 (69.7%)

24 (75.0%)

22 (64.7%)

0.36

Klebsiella spp.

21 (31.8%)

8 (25.0%)

13 (38.2%)

0.25

Mean time from onset of infection to enrollment, days

4.3 ± 1.4

4.2 ± 1.6

4.5 ± 1.2

0.47

Mean duration of pre-enrollment use of group 2 carbapenems, days

2.8 ± 1.6

3.1 ± 1.5

2.6 ± 1.7

0.29

Mean duration of pre-enrollment use of any antibiotics, days

3.1 ± 5.8

3.3 ± 5.4

3.0 ± 6.3

0.82

  1. aAny immunocompromised condition (e.g., HIV infection, receipt of immunosuppressive agents (steroid, cytotoxic agents, and/or chemotherapy))
  2. bAPACHE II score was calculated using data from 10 patients with available arterial blood gas results
  3. cModified APACHE II score was calculated in all patients. For those who did not have arterial blood gas results, the arterial pH was substituted by the level of serum bicarbonate
  4. dAll patients with secondary bacteremia due to UTI (n = 5) were enrolled into the UTI stratum. Other cases of secondary bacteremia were due to cellulitis (n = 1) and spontaneous bacterial peritonitis (n = 1)
  5. eOne patient in the group 2 carbapenems group had bacteremia caused by both Escherichia coli and Klebsiella spp
  6. Abbreviation: APACHE II Acute Physiology and Chronic Health Evaluation II
  7. Data are presented as n (%), mean ± SD; P-value < 0.05 indicates statistical significance