Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
NCT ID: NCT07285213
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2025-12-10
2028-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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AZD5148: dose A
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
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 via intramuscular 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
Participant with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)
Planned surgery for C. difficile infection within 24 hours of enrollment
Current toxic megacolon and/or small bowel ileus
Any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, ie, restrictive procedures such as banding, are permitted).
Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)
Due to receive more than 25 days of antibacterial drug therapy for C. difficile infection for the qualifying C. difficile infection episode
Treatment with a fecal donor transplant or fecal microbiota product in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of C. difficile infection, or planned administration during the 180 days after IMP administration
Treatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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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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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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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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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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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Napoli, , 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
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D8820C00003
Identifier Type: -
Identifier Source: org_study_id