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Recruiting Phase 2

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

NCT07285213 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-12-10
Last updated
2026-10-07

Condition(s) studied

Clostridioides Difficile Infection

Investigational drug(s) / intervention(s)

AZD5148Placebo

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Exclusion Criteria: 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.

Primary outcome measure(s)

  • First occurrence of recurrence of C difficile infection — Day 1 through day 91
    Recurrence of C difficile infection (rCDI) occurring after initial clinical cure (ICC) of the qualifying C difficile infection (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.

Trial sites (117)

FacilityCityRegionStatus
Research Site Phoenix Arizona Withdrawn
Research Site Chula Vista California Withdrawn
Research Site Sacramento California Recruiting
Research Site Torrance California Recruiting
Research Site Hamden Connecticut Recruiting
Research Site Gainesville Florida Withdrawn
Research Site Hialeah Florida Recruiting
Research Site Homestead Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Miami Lakes Florida Withdrawn
Research Site Miramar Florida Withdrawn
Research Site Port Orange Florida Withdrawn
Research Site Tamarac Florida Withdrawn
Research Site Tampa Florida Withdrawn
Research Site Athens Georgia Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Idaho Falls Idaho Recruiting
Research Site Burr Ridge Illinois Recruiting
Research Site Lexington Kentucky Recruiting
Research Site Louisville Kentucky Recruiting
Research Site New Orleans Louisiana Recruiting
Research Site Glen Burnie Maryland Recruiting
Research Site Potomac Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Detroit Michigan Recruiting
Research Site Royal Oak Michigan Recruiting
Research Site Columbia Missouri Recruiting
Research Site Kansas City Missouri Not Yet Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site Union City New Jersey Recruiting
Research Site Hartsdale New York Withdrawn
Research Site Inwood New York Withdrawn
Research Site The Bronx New York Recruiting
Research Site Salisbury North Carolina Recruiting
Research Site Winston-Salem North Carolina Recruiting
Research Site Pittsburgh Pennsylvania Withdrawn
Research Site Johnson City Tennessee Recruiting
Research Site Charlottesville Virginia Recruiting
Research Site Lynchburg Virginia Recruiting

+ 77 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07285213 on ClinicalTrials.gov ↗ ← All trials in Italy