Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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: - 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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind: Participant, Care Provider, Investigator, Outcomes Assessor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AZD5148: dose A
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
  • Drug: AZD5148
    Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Placebo Comparator
Placebo
Participants will receive a single dose of placebo via intramuscular or intravenous push.
  • Other: 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.

Recruiting Locations

Research Site
Hamden 4835654, Connecticut 4831725 06518

Research Site
Gainesville 4156404, Florida 4155751 32605

Research Site
Homestead 4159050, Florida 4155751 33033

Research Site
Jacksonville 4160021, Florida 4155751 32256

Research Site
Idaho Falls 5596475, Idaho 5596512 83404

Research Site
Potomac 4366001, Maryland 4361885 20854

Research Site
Detroit 4990729, Michigan 5001836 48202

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

Approximately 230 participants will be enrolled and randomized 1:1 to receive a single dose of either AZD5148 or placebo (normal saline). Route of administration (intramuscular or intravenous push) will be according to the Investigator's choice. Stratification will be based on geographical region. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.