ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Clinical Trial Data for RebyotaTM and VowstTM
Trial Name (Drug) | A qualifying episode of CDI as defined by | Number of previous CDIs, including qualifying events | Diagnostic Test | Study Design | Primary Endpoint |
---|---|---|---|---|---|
PUNCH CD3 (RebyotaTM) | a) at least one recurrence after a primary episode and has completed at least one round of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year. | At least 1 recurrence after a primary episode (i.e., at least 2 episodes, completed at least 1 round of SoC antibiotics therapy OR at least 2 severe CDI resulting in hospitalization | A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment. | Multicenter, Randomized, Doubleblinded, Placebo-controlled Study | The recurrence of CDI diarrhea within 8 weeks of blinded treatment. |
ECOSPORIII (VowstTM) |
≥3 unformed stools per day for 2 consecutive days A positive C. difficile stool toxin assay. The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin [125 mg QID] and/or fidaxomicin [200 mg BID]). An adequate clinical response following SOC antibiotic therapy, defined as (<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization. |
≥3 CDI episodes within 12 months, inclusive of the current episode | A positive C. difficile stool toxin assay. | Multicenter, randomized,doubleblind, placebo-controlled, parallel-group study | CDI recurrence within 8 weeks of treatment |