TABLE 2

Demographics and baseline disease characteristics (mITT set)a

ParameterValue
CadazolidVancomycin (125 mg QID) (n = 22)Total (n = 78)
250 mg BID (n = 17)500 mg BID (n = 20)1,000 mg BID (n = 19)
Female [n (%)]12 (70.6)16 (80.0)12 (63.2)15 (68.2)55 (70.5)
Age (yr) [mean (SD)]53.6 (20.8)45.4 (16.9)53.6 (17.7)53.2 (19.0)51.4 (18.6)
Caucasian [n (%)]15 (88.2)19 (95.0)16 (84.2)21 (95.5)71 (91.0)
CDI recurrence status [n (%)]
    First occurrence14 (82.4)15 (75.0)16 (84.2)17 (77.3)62 (79.5)
    First recurrence3 (17.6)5 (25.0)3 (15.8)5 (22.7)16 (20.5)
Hospitalization status [n (%)]
    Inpatient3 (17.6)2 (10.0)4 (21.1)5 (22.7)14 (17.9)
    Outpatient14 (82.4)18 (90.0)15 (78.9)17 (77.3)64 (82.1)
Frequency of liquid and unformed stools [n (%)]
    >3 to ≤55 (29.4)6 (30.0)9 (47.4)8 (36.4)28 (35.9)
    ≥6 to ≤108 (47.1)8 (40.0)8 (42.1)9 (40.9)33 (42.3)
    >104 (23.5)6 (30.0)2 (10.5)5 (22.7)17 (21.8)
Severe CDIb [n (%)]
    Yes1 (5.9)1 (5.0)2 (10.5)3 (13.6)7 (9.0)
    No16 (94.1)19 (95.0)17 (89.5)19 (86.4)71 (91.0)
Previous treatment with vancomycin or metronidazole [n (%)]
    Yes1 (5.9)7 (35.0)8 (42.1)7 (31.8)23 (29.5)
    No16 (94.1)13 (65.0)11 (57.9)15 (68.2)55 (70.5)
  • a The mITT analysis set included all randomized patients who received ≥1 dose of study drug and had a confirmed diagnosis of CDI (positive toxigenic culture by a central laboratory).

  • b CDI severity at baseline was defined as any one of the following: white blood cell count of >15,000/mm3, creatinine of >1.5 mg, or core body temperature of >38.5°C.