A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides difficile Infection: The RestoratiVE303 Study

You may be able to join if

• For enrollment in Stage 1 (rCDI population): Age ≥ 12 years where enrollment of adolescents is permitted, and age ≥ 18 years of age or older in other countries, with a laboratory-confirmed qualifying episode of CDI and at least one prior occurrence of CDI within the last 6 months
• Inclusion Criteria for the VE303 Safety Cohort: Inclusion criteria will be identical to the aforementioned Stage 1 population.
• For enrollment in Stage 2 (pCDI-hr population): Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI or Age ≥ 12 years to 74 years where enrollment of adolescents is permitted, and age 18 to 74 in other countries, with a laboratory-confirmed qualifying episode of CDI and at least two of the following risk factors: Age ≥ 65 years Kidney dysfunction, defined as estimated creatinine clearance< 60mL/min/1.73 m2at the time of the qualifying CDI episode 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 History of a prior CDI episode between 6 and 12 months prior to enrollment Immunosuppression due to an underlying disease or its treatment Has undergone solid organ or hematopoietic stem cell transplantation
• For enrollment in either Stage 1 or Stage 2: The qualifying episode of CDI must meet all the following criteria: a. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for at least 2 consecutive days b. CDI symptoms started within 4 weeks prior to the initiation of SoC antibiotic therapy for CDI c. 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 EIA for toxin A/B and GDH, (with PCR reflex testing for discordant GDH/EIA results), as performed at either a local laboratory or the central laboratory d. Diarrhea considered unlikely to have another etiology
• For enrollment in either Stage 1 or Stage 2: Prior to receiving study medication, the participant should: a. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (The choice of SoC agent is at the physician’s discretion. To ensure that adequate antibiotic levels are maintained in the gut to allow for subsequent VE303 strain colonization: i. Vancomycin must be administered at a dosing frequency of at least twice daily. ii. Fidaxomicin must be administered at a dosing frequency of at least once daily. b.Meet the criterion for a successful clinical response, defined as symptomatic control of the qualifying CDI episode, ie, < 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days.
• For enrollment in either Stage 1 or Stage 2: Persons of childbearing potential must have a negative pregnancy test and must agree to either use a highly effective, acceptable form of birth control (highly effective contraception is defined as a method that can achieve a failure rate of less than 1% per year when used consistently and correctly, eg, established hormonal birth control plus a barrier method, hormonal methods of contraception when associated with inhibition of ovulation, including implants, injectables, combined oral contraceptives, some intrauterine devices), remain sexually abstinent during the study period and up to 3 months after the last dose of study drug, or be exclusively with female and/or vasectomized partner(s) who have had medical confirmation of surgical success. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.