TABLE 4

Summary of ceftazidime and avibactam observed and population pharmacokinetic model-predicted exposures in pediatric patients (pharmacokinetic population)

DrugAUC0-∞ (h · mg/liter)
Observed value for cohorta:Predicted value for cohortb:Value for adult reference populationc (n = 16)
1 (≥12 to <18 yr)2 (≥6 to <12 yr)3 (≥2 to <6 yr)4 (≥3 mo to <2 yr)
Ceftazidime230.6 (30.7)221.2 (17.4)255.32 (43.95)286.27 (37.13)289.0d (15.4)
Avibactam36.4 (33.6)34.8 (22.6)43.25 (12.14)48.99 (10.64)42.1e (16.0)
  • a Data for cohorts 1 and 2 are geometric means (percent coefficients of variation).

  • b Data for cohorts 3 and 4 are means (SD) based on population pharmacokinetic model predictions (42).

  • c Values are geometric means (percent coefficients of variation) for observed exposures from a phase I study in healthy adult volunteers on day 1 after receiving a single dose of ceftazidime-avibactam (2,000 to 500 mg) (44).

  • d n = 15.

  • e n = 13.