STUDY DESIGN
| ECOSPOR III |
|---|
|
Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults (≥18 years) with recurrent C. diff 1-3 |
|
Primary Endpoint
Secondary Endpoints
|
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day over 2 days*
|
|
10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID)
|
ECOSPOR III efficacy endpoints based on intent-to-treat population.
Data were rounded to the nearest whole number for presentation.
STUDY DESIGN
ECOSPOR IV was an open-label, single arm study of 263 participants with ≥1 C. diff recurrences evaluating the safety of VOWST; the secondary endpoint was efficacy5
Limitations: open-label study design yields descriptive results limiting interpretations of efficacy and safety without a comparator
| ECOSPOR IV |
|---|
|
Multicenter, open-label, single-arm trial in adults (≥18 years) with recurrent C. diff 5 |
|
Primary Endpoint
Secondary Endpoints
|
|
Recurrence confirmed with
C. diff
toxin test
or
PCR
and ≥3 unformed bowel movements per day over 2 days*
|
|
10–42 days of vancomycin
or 10–25 days of fidaxomicin |
Toxin and PCR testing were utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.
†25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV after experiencing a C. Diff recurrence within 8 weeks.
Data were rounded to the nearest whole number for presentation.