TABLE 3

Efficacy variables (mITT set)a

ParameterValue
CadazolidVancomycin (125 mg QID)
250 mg BID500 mg BID1,000 mg BID
Clinical cure rate [n (%)]13 (76.5)16 (80.0)13 (68.4)15 (68.2)
    80% CI58.4, 89.363.9, 91.051.1, 82.552.3, 81.3
    Treatment group P value (right sided)b0.570.410.83
    n17201922
Recurrence rate [n (%)]2 (18.2)3 (25.0)2 (22.2)7 (50.0)
    80% CI4.9, 41.59.6, 47.56.1, 49.030.5, 69.5
    n1112914
Sustained clinical response rate [n (%)]9 (60.0)9 (56.3)7 (46.7)8 (33.3)
    80% CI40.4, 77.437.5, 73.728.2, 65.819.6, 49.7
    n15161521
Median time to resolution of diarrhea (h)141.2173.6135.5133.7
    80% CI107.3, 180.786.7, 212.1110.8, 286.390.7, 190.9
    n17201922
  • 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 The clinical cure rate vs. the prespecified 75% cure rate was tested with a one-sided 10% exact binomial test.