TABLE 1

Patient demographics and baseline characteristics in the ITT, MITT, and ME populations

CharacteristicValue by population
ITT (n = 103)MITT (n = 87)ME (n = 76)
Age (y)
    Mean (SDa)40.6 (12.6)40.2 (12.7)40.6 (13.0)
    Minimum, maximum19, 6419, 6419, 64
Male66 (64.1)58 (66.7)49 (64.5)
Mean (SD) duration of infection (days)5.6 (3.4)5.5 (3.5)5.5 (3.6)
No. (%) of patients by primary infection type
    Wound infection36 (35.0)32 (36.8)27 (35.5)
    Cutaneous abscess40 (38.8)31 (35.6)30 (39.5)
    Cellulitis28 (27.2)25 (28.7)20 (26.3)
No. (%) of patients by severity of infection
    Mild3 (2.9)1 (1.1)0 (0.0)
    Moderate77 (74.8)66 (75.9)57 (75.0)
    Severe23 (22.3)20 (23.0)19 (25.0)
No. (%) of patients with complicating factor
    Illicit drug user56 (54)
    HIV infection3 (2.9)
    Hepatitis C infection26 (25.2)
    Hepatitis B infection2 (1.9)
    Past or present tuberculosis4 (3.9)
Mean (SD) baseline assessments
    Investigator measurement (cm2)
        Area of erythema259.7 (200.9)264.3 (213.9)263.4 (211.8)
        Area of induration125.0 (123.9)126.3 (124.2)129.7 (129.9)
        Area of swelling and/or edema205.3 (233.4)210.8 (248.95)212.1 (260.76)
    Acetate tracing sheet assessment (cm2)
        Area of erythema202.6 (154.2)205.7 (163.5)208.4 (166.0)
        Area of indurationb97.2 (92.5)98.6 (92.8)101.2 (96.9)
        Area of abscessc9.9 (15.1)8.9 (10.5)9.2 (11.0)
  • a SD, standard deviation.

  • b Values for the mean area of induration were 101, 86, and 76 cm2 in the ITT, MITT, and ME populations, respectively.

  • c Values for the mean area of abscess were 66, 53, and 47 cm2 in the ITT, MITT, and ME populations, respectively.