TABLE 2

Baseline patient characteristics (safety analysis population)

ParameterValue for cohort:
1 (≥12 to <18 yr) (n = 8)2 (≥6 to <12 yr) (n = 8)3 (≥2 to <6 yr) (n = 8)4 (≥3 mo to <2 yr) (n = 8)
Age, yr
    Mean (SD)14.9 (1.6)8.0 (1.4)3.5 (1.0)0.9 (0.5)
    Median (range)14.9 (13.0–17.3)7.7 (6.5–10.8)3.8 (2.1–4.9)0.9 (0.3–1.8)
Female, n (%)5 (62.5)3 (37.5)6 (75.0)3 (37.5)
Race, n (%)
    White6 (75.0)6 (75.0)7 (87.5)5 (62.5)
    Black or African American1 (12.5)2 (25.0)03 (37.5)
    Othera1 (12.5)01 (12.5)0
Weight, kg; mean (SD)51.90 (7.15)24.95 (3.03)15.73 (2.39)9.20 (2.51)
BMI, kg/m2; mean (SD)20.80 (3.21)15.41 (0.78)15.47 (0.95)NAd
CrCL, ml/min/1.73 m2; mean (SD)115.29 (18.14)156.97b (42.92)181.57 (100.99)104.35 (26.20)
Normal renal function, n (%)8 (100)8 (100)8 (100)8 (100)
Any concomitant antibiotic,c n (%)8 (100)8 (100)8 (100)8 (100)
    Lincosamides3 (37.5)2 (25.0)4 (50.0)6 (75.0)
    3rd-generation cephalosporins other than ceftazidime1 (12.5)3 (37.5)1 (12.5)1 (12.5)
    Penicillins plus β-lactamase inhibitors1 (12.5)02 (25.0)2 (25.0)
    Vancomycin1 (12.5)1 (12.5)02 (25.0)
    Metronidazole2 (25.0)2 (25.0)00
    Aminoglycosides2 (25.0)1 (12.5)01 (12.5)
    1st-generation cephalosporins1 (12.5)01 (12.5)1 (12.5)
    Azithromycin1 (12.5)1 (12.5)1 (12.5)0
    Extended-spectrum penicillin1 (12.5)1 (12.5)1 (12.5)0
    Meropenem02 (25.0)00
    Levofloxacin002 (25.0)0
  • a Asian (n = 1 in cohort 3 [≥2 to <6 years]) and American Indian or Alaskan native (n = 1 in cohort 1 [≥12 to <18 years]).

  • b One patient in cohort 2 (≥6 to <12 years) had a value greater than the upper limit of normal and is not included in the mean (SD) calculation.

  • c Taken any time between the initiation of study therapy and the day 3 follow-up assessment. Most commonly used antibiotics/groups are shown.

  • d NA, not applicable.