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Table 3 Primary and secondary outcomes

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

Meropenem + levofloxacin group

Risk ratio (95% CI) for the outcome with colistin

p value

Efficacy

 Primary outcome

  Mortality at 28 days in the mMITT population (n = 157)

19/82 (23.2)

19/75 (25.3)

0.91 (0.53, 1.59)

0.752

 Secondary outcomes

  Mortality at 28 days in the MITT population (n = 232)

27/120 (22.5)

24/112 (21.4)

1.05 (0.65, 1.71)

0.844

  Mortality at 28 days with CR-GNB (n = 36)

5/20 (25.0)

6/16 (35.2)

0.67 (0.25, 1.79)

0.425

  Clinical cure in the MITT population (n = 232)

82 (68.3)

81 (72.3)

0.94 (0.80, 1.12)

0.507

  Microbiological cure in the mMITT population (n = 157)

46 (56.1)

42 (56.0)

1.00 (0.76, 1.32)

0.990

  Microbiological failure in the mMITT population (n = 157)

33 (40.2)

31 (41.3)

0.97 (0.67, 1.42)

0.899

  Microbiological relapse in the mMITT population (n = 157)

3 (3.7)

2 (2.7)

1.37 (0.24, 7.99)

0.723

Safety

 Serious adverse events (n = 232)

50 (41.7)

45 (40.2)

1.04 (0.76–1.41)

0.818

 Serious adverse events* (n = 232)

4 (3.3)

1 (0.9)

3.70 (0.42, 32.90)

0.201

 CrCl (ml/h) at the end of the treatment day (n = 231)

90.9 [57.2–141.9]

122.3 [86.1–185.7]

−37.93 (− 62.96, − 12.90)

0.003

 Renal replacement therapy (n = 232)

11 (9.1)

2 (1.7)

5.13 (1.16, 22.65)

0.015

RIFLE score at the end of treatment compared with randomization (n = 232)μ

n = 120

n = 112

0.034¥

 None

80 (66.7)

91 (81.3)

 Risk

21 (17.5)

11 (9.8)

 Injury

15 (12.5)

5 (4.5)

 Failure

4 (3.3)

5 (4.5)

  1. CI confidence interval, mMITT microbiologically modified intention-to-treat, MITT modified intention-to-treat, CR-GNB carbapenem-resistant gram-negative bacilli, CrCl creatinine clearance, RRT renal replacement treatment
  2. *Serious adverse events suspected of being related to the study medications according to the investigator’s opinion (4 cases of renal insufficiency/renal impairment attributed to colistin and 1 case of compartment syndrome related to meropenem), (%) [range]
  3. μNo patients with RRT > 4 weeks (equivalent to RIFLE score of “Loss”) and no patients with permanent dialysis > 3 months (equivalent to RIFLE score of “End Stage Kidney Disease”)
  4. ¥p for trend