Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CDI
- Clostridium Difficile
- Clostridium Difficile Infection
- Clostridium Difficile Infection Recurrence
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This Phase 2 study will help determine how safe and effective the study drug, VE303, is at preventing subsequent Clostridium difficile Infection (CDI)-associated diarrhea compared with placebo, following completion of at least 1 successful course of standard-of-care (SOC) antibiotics for subjects with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent CDI. Patients in the study will be randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors will all be masked to study treatment assignment.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in prevention of subsequent CDI-associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo...
CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in prevention of subsequent CDI-associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules will be taken orally for 14 days after completion of a course of standard of care antibiotics. The proportion of subjects experiencing a confirmed CDI recurrence, within 8 weeks after the first dose of study treatment, will be compared across the study arms to understand the effectiveness of VE303 in preventing rCDI. The study will enroll approximately 146 to 300 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must also have a positive C. difficile stool sample and have responded to standard of care (SOC) antibiotic treatment.
Tracking Information
- NCT #
- NCT03788434
- Collaborators
- Not Provided
- Investigators
- Not Provided