| OPT-80 (200 mg bid) | Vancomycin (125 mg qid) | P-value | 95% CI | |
|---|---|---|---|---|
| Per Protocol Analysis | ||||
| Clinical cure, % (n/N) | 92.1% (244/265) | 89.8% (254/283) | NA | −2.6,a |
| Recurrence, % (n/N) | 13.3% (28/211) | 24.0% (53/221) | 0.004 | −17.9, −3.3 |
| Global cure, % (n/N) | 77.7% (206/265) | 67.1% (190/283) | 0.006 | 3.1, 17.9 |
| Modified Intent-to-Treat (mITT) Analysis | ||||
| Clinical cure, % (n/N) | 88.2% (253/287) | 85.8% (265/309) | NA | −3.1,a |
| Recurrence, % (n/N) | 15.4% (39/253) | 25.3% (67/265) | 0.005 | −16.6, −2.9 |
| Global cure, % (n/N) | 74.6% (214/287) | 64.1% (198/309) | 0.006 | 3.1, 17.7 |
CI, confidence interval; NA, not applicable (non-inferiority end point was met).
a
One-sided 97.5%CI.