Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Start Date
12/10/2025
Completion Date
1/18/2028
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.
Detailed 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 Criteria
Age Range: 18 years to No maximum
Interventions
AZD5148
Placebo
Conditions
Locations
Research Site
Phoenix, Arizona 85032
United States
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Chula Vista, California 91911
United States
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Sacramento, California 95817
United States
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Torrance, California 90502
United States
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Hamden, Connecticut 06518
United States
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Gainesville, Florida 32605
United States
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Hialeah, Florida 33016
United States
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Homestead, Florida 33033
United States
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Jacksonville, Florida 32256
United States
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Miami Lakes, Florida 33014
United States
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Miramar, Florida 33027
United States
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Port Orange, Florida 32127
United States
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Tamarac, Florida 33321
United States
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Tampa, Florida 33607
United States
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Athens, Georgia 30606
United States
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Atlanta, Georgia 30322
United States
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Idaho Falls, Idaho 83404
United States
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Burr Ridge, Illinois 60527
United States
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Lexington, Kentucky 40509
United States
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Louisville, Kentucky 40202
United States
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New Orleans, Louisiana 70121
United States
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Glen Burnie, Maryland 21061
United States
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Potomac, Maryland 20854
United States
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Boston, Massachusetts 02114
United States
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Boston, Massachusetts 02115
United States
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Detroit, Michigan 48202
United States
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Royal Oak, Michigan 48073
United States
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Columbia, Missouri 65212
United States
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St Louis, Missouri 63130
United States
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Union City, New Jersey 07087
United States
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Hartsdale, New York 10530
United States
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Inwood, New York 11096
United States
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The Bronx, New York 10451
United States
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Salisbury, North Carolina 28144
United States
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Winston-Salem, North Carolina 27103
United States
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Pittsburgh, Pennsylvania 15237
United States
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Johnson City, Tennessee 37614
United States
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Charlottesville, Virginia 22903
United States
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Lynchburg, Virginia 24501
United States
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Roanoke, Virginia 24014
United States
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Seattle, Washington 98109
United States
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Madison, Wisconsin 53705
United States
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Camperdown, 2050
Australia
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Clayton, 3168
Australia
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Herston, 4029
Australia
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Melbourne, 3000
Australia
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South Brisbane, 4101
Australia
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Edmonton, Alberta T6G 2X8
Canada
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Vancouver, British Columbia V5Z 1M9
Canada
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Victoria, British Columbia V8T 5G4
Canada
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Halifax, Nova Scotia B3K 6R8
Canada
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Hamilton, Ontario L8N 4A6
Canada
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London, Ontario N6A 5A5
Canada
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Montreal, Quebec H4A 3S5
Canada
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Québec, Quebec G1V 4T3
Canada
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Sherbrooke, Quebec J1H 5N4
Canada
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Aarhus N, 8200
Denmark
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Gistrup, 9260
Denmark
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Hvidovre, 2650
Denmark
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København Ø, 2100
Denmark
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Odense C, 5000
Denmark
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Lyon, 69317
France
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Montpellier, 34295
France
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Nantes, 44093
France
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Nîmes, 30029
France
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Paris, 75014
France
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Paris, 75475
France
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Tours, 37044
France
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Augsburg, 86156
Germany
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Berlin, 13353
Germany
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Cologne, 50937
Germany
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Frankfurt, 60590
Germany
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Hamburg, 20246
Germany
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Jena, 07747
Germany
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Leipzig, 04103
Germany
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München, 81675
Germany
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Athens, 11527
Greece
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Athens, 12462
Greece
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Heraklion, 71500
Greece
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Ioannina, 45500
Greece
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Thessaloniki, 57010
Greece
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Budapest, 1082
Hungary
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Debrecen, 4031
Hungary
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Eger, 3300
Hungary
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Kistarcsa, 2143
Hungary
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Pécs, 7624
Hungary
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Modena, 41124
Italy
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Naples, 80131
Italy
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Palermo, 90127
Italy
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Pisa, 56124
Italy
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Roma, 00161
Italy
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Varese, 21100
Italy
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Kochi, 780-8522
Japan
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Kumamoto, 861-8520
Japan
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Meguro-ku, 153-0051
Japan
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Nagasaki, 852-8501
Japan
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Shimonoseki-shi, 750-8520
Japan
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Yaizu-shi, 425-8505
Japan
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Lublin, 20-081
Poland
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Warsaw, 04-141
Poland
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Alicante, 03010
Spain
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Badalona, 08916
Spain
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Madrid, 28007
Spain
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Madrid, 28034
Spain
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Madrid, 28040
Spain
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Madrid, 28046
Spain
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Majadahonda, 28220
Spain
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Seville, 41009
Spain
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Helsingborg, 25187
Sweden
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Lund, 22185
Sweden
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Malmö, 20502
Sweden
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Västerås, 72189
Sweden
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Birmingham, B15 2TH
United Kingdom
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Cambridge, CB2 0QQ
United Kingdom
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Cardiff, CF14 4XW
United Kingdom
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Newcastle, NE14LP
United Kingdom