This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).
CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention of subsequent Clostridioides difficile infection (CDI) -associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI recurrence within 8 weeks after the first dose of study treatment were compared across the study arms, to understand the efficacy of VE303 in preventing rCDI. The study originally planned to enroll 146 subjects but through a protocol amendment was revised to an enrollment target of 60 to 80 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must have had a positive C. difficile stool sample and have responded to SOC antibiotic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
79
VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.
Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.
Phoenix Clinical, LLC
Phoenix, Arizona, United States
Mayo Clinic, Clinical Studies Unit
Phoenix, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Alliance Research Institute
Canoga Park, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
CDI Recurrence Week 8
Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment).
Time frame: 8 weeks
VE303 Strains Detected
Characterize the number of VE303 strains detected in the fecal microbiome at week 24.
Time frame: 24 weeks
VE303 Relative Abundance
Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ventura Clinical Trials
Ventura, California, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Gastro Florida
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
...and 27 more locations