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Table 1 Patient, infection, and treatment characteristics

From: Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial

 

Colistin + levofloxacin group (n = 120)

Meropenem + levofloxacin group (n = 112)

p value

Age, years (n = 232)

63 [49–71]

60.5 [50–70]

0.370

Female (n = 232)

28 (23.3)

31 (27.7)

0.448

Underlying diseases (n = 232)

41 (34.2)

38 (33.9)

0.969

 Diabetes mellitus

19 (15.8)

22 (19.6)

0.447

 Chronic liver disease

6 (5.0)

5 (4.5)

0.848

 Congestive heart failure

2 (1.7)

2 (1.8)

0.945

 Chronic renal disease

1 (0.8)

4 (3.6)

0.151

 Chronic obstructive pulmonary disease

21 (17.5)

10 (8.9)

0.055

 Neoplasia

5 (4.2)

3 (2.7)

0.535

Infection characteristics (n = 232)

 Days from MV to VAP

8 [6–11]

7.5 [6–11]

0.844

 Clinical presentation

  Sepsis

67 (55.8)

62 (55.4)

0.992

  Severe sepsis

27 (22.5)

26 (23.2)

 

  Septic shock

26 (21.7)

24 (21.4)

 

 APACHE II trial inclusion—VAP diagnosis

19 [14–24]

17 [13–22]

0.065

  APACHE II ≤ 15

40 (33.3)

46 (41.1)

0.223

  APACHE II > 15

80 (66.7)

66 (58.9)

 

 Multilobar infiltrates (Rx film)

69 (57.5)

54 (48.2)

0.157

 Baseline CPIS

6 [4–7]

5 [4–7]

0.662

 Baseline creatinine clearance (mg/h) (n = 231)

101.0 [70.9–131.0]

113.0 [66.8–163.4]

0.424

 Microbiological diagnosis (n = 157)

82 (52.2)

75 (47.8)

0.824

 VAP caused by A. baumannii, P. aeruginosa, and K. pneumoniae (n = 79)

40 (48.8)

39 (52)

0.811

 MIC distribution

  Meropenem MIC

   ≤ 2 mg/l—susceptible

16 (40)

18 (46.2)

0.719

   > 2–8 mg/l—intermediate

4 (10)

5 (12.8)

   > 8 mg/l—resistant1

20 (50)

16 (41)

  Colistin MIC

   ≤ 2 mg/l—susceptible2

35 (87.5)

32 (82.1)

0.500

   > 2 mg/l—resistant

5 (12.5)

7 (17.9)

  Levofloxacin MIC

   ≤ 2 mg/l—susceptible

16 (40)

17 (43.6)

0.746

   > 2 mg/l—resistant

24 (60)

22 (56.4)

 Bacteremia (n = 232)

21 (17.5)

17 (15.2)

0.633

Treatment (n = 232)

 Empirical treatment with vancomycin

19 (15.8)

19 (17)

0.816

 Empirical treatment with linezolid

17 (14.8)

18 (16.4)

0.744

 Appropriate empirical antibiotic treatment (n = 157)

65 (79.3)

54 (72)

0.288

 Duration of antibiotic treatment

  Days of treatment (n = 232)

9 [5–14]

7.9 [5–11]

0.035

  Days of levofloxacin (n = 232)

8 [5–13]

7 [4–9]

0.003

  1. The data are expressed as n, n (%), and the median (IQR) unless otherwise indicated
  2. MV mechanical ventilation, VAP ventilator-associated pneumonia, APACHE Acute Physiology and Chronic Health Evaluation, Rx radiographic film, GNB gram-negative bacilli, CPIS Clinical Pulmonary Infection Score
  3. 1Definition according to the EUCAST 2012 recommendations and criteria. Carbapenem-resistant gram-negative bacteria (MIC > 8 mg/l). Colistin-resistant gram-negative bacteria (MIC > 2 mg/l for A. baumannii and Enterobacteriaceae and > 4 mg/l for P. aeruginosa). EUCAST. Breakpoint tables for interpretation of MICs and zone diameters version 2.0, valid from 2012 to 01-01. http://www.eucast.org/ast_of_bacteria/previous_versions_of_documents/
  4. 2Includes P. aeruginosa; all of these isolates had an MIC breakpoint ≤ 4 mg/l (susceptible)