Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 stoo