A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above (PRISM)

未提供0 个研究点目标入组 10 人开始时间: 待定

适应症

试验速览

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•Participant must be >_ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent.
•Participants with a qualifying C. difficile infection episode at the time of providing informed consent defined by:
•Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformed stool sample collected during this episode, and
•Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned duration of at least 10 and at most 25 days at time of IMP administration.
•Note: Diarrhea is not required to be present on the day of investigational medicinal product (IMP) administration.
•Body weight >_ 40 kg

•History of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease, microscopic colitis).
•Participant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)
•Planned surgery for C. difficile infection within 24 hours of enrollment
•Current toxic megacolon and/or small bowel ileus
•Any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).
•Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)
•Due to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode
•Treatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, or planned administration during the 180 days after IMP administration
•Treatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.

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