약학회지

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Table. 5.

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
Yakhak Hoeji 2024;68:159-67 https://doi.org/10.17480/psk.2024.68.3.159
© 2024 Yakhak Hoeji