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Table 3 Outcomes 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

Outcomes

De-escalation (n = 32)

Non-de-escalation (n = 34)

P-value

Clinical outcomes

 Clinical cure rate

30 (93.8%)

24 (79.4%)

0.09

 Microbiological eradication ratea

20/20 (100.0%)

23/24 (95.8%)

0.36

 28-day mortality rate

3 (9.4%)

10 (29.4%)

0.05b

  • ID-related mortality

1 (3.1%)

9 (26.5%)

0.01b

  • Non ID-related mortality

1 (3.1%)

1 (2.9%)

1.00b

 Superimposed infection rate

6 (18.8%)

12 (35.3%)

0.13

  • Acinetobacter baumannii

2 (6.3%)

6 (17.3%)

0.26b

  • MRSA

2 (6.3%)

3 (8.8%)

1.00b

  • Candida spp.

1 (3.1%)

4 (11.8%)

0.51b

  • Pseudomonas aeruginosa

2 (6.3%)

2 (5.9%)

1.00b

  • Enterococcus spp.

2 (6.3%)

0

0.23b

Cost-related outcomes

 Median length of stay, days

16.5 (4.0–73.0)

20.0 (1.0–112.0)

0.04b

 Median length of stay after enrollment, days

9.5 (0–37.0)

11.5 (1.0–102.0)

0.11b

 Mean duration of carbapenem use, days

14.4 ± 6.0

16.5 ± 10.5

0.32

 Mean DDD of carbapenem

12.9 ± 8.9

18.4 ± 12.6

0.05

Stool colonization

N = 32

N = 32c

 

 At baseline

  • Any MDR bacteria

20 (62.5%)

21 (65.6%)

1.0

  • Any ESBL-producing GNB

19 (59.4%)

20 (62.5%)

1.0

  • MDR-Acinetobacter baumannii

4 (12.5%)

3 (9.4%)

1.0b

  • MDR-Pseudomonas aeruginosa

0

1 (3.1%)

1.0b

 At the end of therapy

  • Any MDR bacteria

16 (50.0%)

11 (34.4%)

0.31

  • Any ESBL-producing GNB

11 (34.4%)

8 (25.0%)

0.59

  • MDR-Acinetobacter baumannii

6 (18.8%)

4 (12.5%)

0.73b

  • MDR-Pseudomonas aeruginosa

1 (3.1%)

0 (0.0%)

1.0b

  1. aMicrobiological eradication was calculated in patients who had a follow-up culture of the infection site
  2. bNonparametric test
  3. cTwo patients in the group 2 carbapenem group had a contraindication for rectal swab culture
  4. Abbreviations: MRSA methicillin-resistant Staphylococcus aureus, DDD defined daily dose, MDR multi-drug resistant, ESBL extended-spectrum beta-lactamase enzyme, GNB Gram-negative bacteria
  5. Data are presented as n (%), mean ± SD or median (range); P-value < 0.05 indicates statistical significance