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Table 2 Pharmacokinetic primary and secondary outcomes

From: Right dose, right now: bedside, real-time, data-driven, and personalised antibiotic dosing in critically ill patients with sepsis or septic shock—a two-centre randomised clinical trial

 

AutoKinetics

N = 115

Control

N = 91

delta estimate

(confidence interval)

Odds ratio

(confidence interval)

p value

Target attainment within 24 h, n / N (%)

Vancomycin

12/12 (100%)

13/14 (93%)

 

Inf (0.02 to inf)x

1x

Ciprofloxacin

29/42 (69%)

1/29 (3%)

 

62.5 (11.4 to 1173.78)a

< 0.001

Meropenem

12/19 (63%)

12/15 (80%)

 

0.42 (0.07 to 1.95)a

0.291

Ceftriaxone

37/39 (95%)

31/32 (97%)

 

0.60 (0.03 to 6.51)a

0.679

Fraction of days with target attainment (FTA)—median (IQR)

Vancomycin

1 (1 to 1)

1 (0.93 to 1)

0.01 (− 0.18 to 0.58)b

 

0.42

Ciprofloxacin

1 (0.5 to 1)

0 (0 to 0)

0.65 (0.42 to 0.88)b

 

< 0.001

Meropenem

1 (0 to 1)

1 (0.75 to 1)

− 0.15 (− 0.45 to 0.18)b

 

0.413

Ceftriaxone

1 (1 to 1)

1 (1 to 1)

− 0.08 (− 0.08 to 0.01)b

 

0.889

Time in hours to target attainment (TTA)—median (IQR)

Vancomycin

7 (0 to 8.3)

10 (6.1 to 13.5)

− 3.23 (− 7.38 to 0.92)c

 

0.141

Ciprofloxacin

17.7 (14.1 to 23.1)

41.2 (33.0 to 54.4)

− 26.00 (− 32.45 to −  18.71)c

 

< 0.001

Meropenem

4.97 (0 to 20.0)

0.08 (0 to 18.6)

2.87 (− 8.26 to 14.42)c

 

0.618

Ceftriaxone

14.9 (6.4 to 18.4)

18.2 (10.2 to 18.9)

− 2.10 (− 6.06 to 1.69)c

 

0.276

  1. The target was defined as 75%-T0-24 > 4⋅MIC for ceftriaxone and meropenem, where 75%T0-24 denotes 75% of the time. For vancomycin, target was defined as AUC0-24/MIC > 300 and for ciprofloxacin as AUC0-24/MIC > 94, which is also 75% of the target used for AutoKinetics dose advice
  2. IQR, Interquartile Range; SD, standard deviation
  3. xFisher’s exact test was used for null-hypothesis testing and confidence interval calculation due to the 100% target attainment in the antibiotic group rather than a generalised linear mixed model
  4. aOdds ratio with confidence interval around the odds, calculated using a generalised linear mixed model on a binomial distribution
  5. bDifference in fraction of days with target attainment with confidence interval, calculated based on a linear mixed model
  6. cDifference in hours to target attainment with confidence interval, calculated based on a linear mixed model. A negative TTA difference indicates a reduction in time to target attainment for the AutoKinetics group compared to control
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