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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 groupMeropenem + levofloxacin groupRisk ratio (95% CI) for the outcome with colistinp 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)μn = 120n = 1120.034¥
 None80 (66.7)91 (81.3)
 Risk21 (17.5)11 (9.8)
 Injury15 (12.5)5 (4.5)
 Failure4 (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