Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Clostridioides Difficile Infection

In brief

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.

Key facts

Study ID

NCT07285213

Run by

AstraZeneca

People needed

230

Starts

2025-12-10

Expected to finish

2028-01-18

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days, (Note: Diarrhea is not required to be present on the day of IMP administration) and
• Positive local C. difficile toxin test (eg, immune assay or CCNA) on a stool sample collected during this episode, as part of routine clinical care (Note: Toxin testing, where not part of routine clinical care, may be conducted as a pre- screening activity; if this occurs, participant consent is required), and
• Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode,
• Note: At the time of randomization and IMP administration, the participant must have started receiving the antibacterial drug therapy with a planned total treatment duration of at least 10 and at most 28 days at time of IMP administration. IMP can be administered at any point during the antibacterial drug therapy.
• Body weight ≥ 35 kg

You may not qualify if…

• Participants with a history of uncontrolled inflammatory bowel disease. Participants with a history of inflammatory bowel disease may be included if, in the opinion of the Investigator, their disease is clinically controlled and presenting symptoms are more likely attributable to CDI than to a flare of inflammatory bowel disease.
• Participants 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
• 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 28 days of antibacterial drug therapy for the qualifying C. difficile infection episode
• Participants receiving a fecal microbiota transplant, fecal microbiota product, or live biotherapeutic product for the qualifying CDI episode, 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.

Where it is running

• Research Site — The Bronx, New York, United States (enrolling)
• Research Site — Roanoke, Virginia, United States (enrolling)
• Research Site — Torrance, California, United States (enrolling)
• Research Site — Columbia, Missouri, United States (enrolling)
• Research Site — Winston-Salem, North Carolina, United States (enrolling)
• Research Site — Lynchburg, Virginia, United States (enrolling)
• Research Site — Homestead, Florida, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Detroit, Michigan, United States (enrolling)
• Research Site — Miramar, Florida, United States (enrolling)
• Research Site — Salisbury, North Carolina, United States (enrolling)
• Research Site — Tamarac, Florida, United States (enrolling)
• Research Site — Johnson City, Tennessee, United States (enrolling)
• Research Site — Athens, Georgia, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Idaho Falls, Idaho, United States (enrolling)
• Research Site — Burr Ridge, Illinois, United States (enrolling)
• Research Site — Lexington, Kentucky, United States (enrolling)
• Research Site — Hamden, Connecticut, United States (enrolling)
• Research Site — New Orleans, Louisiana, United States (enrolling)
• Research Site — Glen Burnie, Maryland, United States (enrolling)
• Research Site — Potomac, Maryland, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Gainesville, Florida, United States (enrolling)
• Research Site — Camperdown, Australia (enrolling)

Full record on ClinicalTrials.gov

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