Phase IIb Trial of AZD5148 to Prevent Clostridioides difficile Infection Recurrence in Adults Single Dose Administration by Injection or Intravenous Push Randomized, Placebo-Controlled Study

What this Trial Is About

Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 and older. This Phase IIb study aims to compare a single dose of AZD5148 with a placebo to better understand its potential role in reducing recurrent infections. The study involves approximately 230 participants randomized equally to receive either the active drug or placebo. Participants will receive one dose of AZD5148 or placebo, administered either by intramuscular injection or intravenous push based on the investigators choice. The study includes up to two site visits for eligibility confirmation and dose administration, including stool sample collection. Following treatment, there will be up to seven planned visits with weekly contacts initiated by the study staff, transitioning later to monthly follow-ups. Participants will also complete an electronic diary to record relevant information. During the study, participants will undergo various assessments including stool testing, monitoring of diarrhea symptoms, and evaluation of any recurrence of infection up to 91 days after dosing. Safety assessments will include monitoring for immediate and delayed adverse events, injection site reactions, and serious adverse events up to 361 days. Pharmacokinetics and immune response to AZD5148 will also be evaluated. The total participation period spans from initial screening through follow-up visits extending up to nearly one year after treatment.

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody