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)
Facility
City
Region
Status
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.
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.
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