VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Inclusion Criteria

• •Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months
• •Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
• •OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
• •1. Age ≥ 65 years
• •2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode
• •3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study
• •4. History of a prior CDI episode between 6 and 12 months prior to enrollment
• •5. Immunosuppression due to an underlying disease or its treatment
• •6. Has undergone solid organ or hematopoietic stem cell transplantation
• •The qualifying episode of CDI must meet all the following criteria:
• •1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
• •2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
• •3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory
• •4. Diarrhea considered unlikely to have another etiology
• •Prior to receiving any study medication, the participant should:
• •1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.
• •2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days
• •Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing
• •Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization