Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
PRISM
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
1 other identifier
interventional
230
14 countries
114
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2025
CompletedStudy Start
First participant enrolled
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 18, 2028
May 5, 2026
May 1, 2026
1.4 years
November 20, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First occurrence of recurrence of C difficile infection
rCDI is a recurrence of C difficile infection (CDI) occurring after initial clinical cure of the qualifying CDI. CDI is defined as a history of diarrhea (\>=3 unformed stools, ie, type 6 or 7 stool on Bristol Stool Scale in \<=24 hours for 2 consecutive calendar days) accompanied by a positive stool test for C difficile toxin.
Day 1 through day 91
Secondary Outcomes (17)
Sustained clinical cure
Day 91
Duration of recurrent C difficile infection
Day 1 through Day 91
First occurrence of severe recurrent C difficile infection
Day 1 through Day 91
First occurrence of fulminant recurrent C difficile infection
Day 1 through Day 91
Severity of participant reported diarrhea symptoms
Day 1 through Day 91
- +12 more secondary outcomes
Study Arms (2)
AZD5148: dose A
EXPERIMENTALParticipants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Placebo
PLACEBO COMPARATORParticipants will receive a single dose of placebo via intramuscular or intravenous push.
Interventions
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
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
You may qualify if:
- 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 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
You may not qualify if:
- History of inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease, microscopic colitis).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (114)
Research Site
Phoenix, Arizona, 85032, United States
Research Site
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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Aalborg, DK9000, Denmark
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Aarhus N, 8200, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind: Participant, Care Provider, Investigator, Outcomes Assessor
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 16, 2025
Study Start
December 10, 2025
Primary Completion (Estimated)
April 20, 2027
Study Completion (Estimated)
January 18, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.