Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03595553 | Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection | PHASE3 | COMPLETED | 759 | — | — | Jan 28, 2019 | Nov 17, 2021 | Mar 3, 2023 | 149 | United States, Argentina +12 |
This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs \& symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.
| Arm | Type | Description |
|---|---|---|
| ridinilazole | EXPERIMENTAL | ridinilazole 200mg bid |
| vancomycin | ACTIVE_COMPARATOR | vancomycin 125 mg qid |
| Name | Type | Description |
|---|---|---|
| Ridinilazole | DRUG | ridinilazole (200 mg bid) |
| Vancomycin | DRUG | vancomycin (125 mg qid) |
Inclusion Criteria Patients are eligible to be included in the study only if all the following criteria apply: 1. Patient must be at least 18 years of age, at the time of signing the informed consent. 2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI...