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Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2025-12-10
Completion Date
2028-01-18
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
AZD5148
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Placebo
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 (113)
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Phoenix, Arizona, United States
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Chula Vista, California, United States
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Sacramento, California, United States
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Torrance, California, United States
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Hamden, Connecticut, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Miami Lakes, Florida, United States
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Miramar, Florida, United States
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Port Orange, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Burr Ridge, Illinois, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Glen Burnie, Maryland, United States
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Potomac, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Hartsdale, New York, United States
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Inwood, New York, United States
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The Bronx, New York, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Pittsburgh, Pennsylvania, United States
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Johnson City, Tennessee, United States
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Charlottesville, Virginia, United States
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Lynchburg, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Camperdown, Australia
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Clayton, Australia
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Herston, Australia
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Melbourne, Australia
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South Brisbane, Australia
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Aalborg, Denmark
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Aarhus N, Denmark
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Hvidovre, Denmark
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København Ø, Denmark
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Odense C, Denmark
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Lyon, France
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Montpellier, France
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Nantes, France
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Nîmes, France
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Paris, France
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Paris, France
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Tours, France
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Augsburg, Germany
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Berlin, Germany
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Cologne, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Jena, Germany
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Leipzig, Germany
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München, Germany
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Athens, Greece
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Athens, Greece
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Heraklion, Greece
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Ioannina, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Kistarcsa, Hungary
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Pécs, Hungary
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Modena, Italy
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Naples, Italy
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Palermo, Italy
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Pisa, Italy
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Roma, Italy
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Varese, Italy
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Kochi, Japan
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Kumamoto, Japan
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Meguro-ku, Japan
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Nagasaki, Japan
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Shimonoseki-shi, Japan
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Yaizu-shi, Japan
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Lublin, Poland
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Warsaw, Poland
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Alicante, Spain
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Badalona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Seville, Spain
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Helsingborg, Sweden
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Lund, Sweden
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Malmo, Sweden
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Västerås, Sweden
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Birmingham, United Kingdom
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Cambridge, United Kingdom