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
AstraZeneca
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.
Description
Approximately 230 participants will be enrolled and randomized 1:1 to receive a single dose of either AZD5148 or placebo (normal saline). Route of administration (intramuscular or intravenous push) will be according to the Investigator's choice. Stratification will be based on geographical region. Study details include: * Up to 2 site visits for confirmation of eligibility and dose administration, including stool sample collection; * Up to 7 planned visits; * Contacts initiated by site staff -weekly, later monthly follow up; * Electronic diary completion.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAZD5148
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
- OtherPlacebo
Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.
Locations (114)
- Research SitePhoenix, Arizona
- Research SiteChula Vista, California
- Research SiteSacramento, California
- Research SiteTorrance, California
- Research SiteHamden, Connecticut
- Research SiteGainesville, Florida