NCT07285213
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 230
- Locations
- 138
- Primary Endpoint
- First occurrence of recurrence of C difficile infection
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind: Participant, Care Provider, Investigator, Outcomes Assessor
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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.
Arms & Interventions
Placebo
Placebo Comparator
Participants will receive a single dose of placebo via intramuscular or intravenous push.
Intervention: Placebo (Other)
AZD5148: dose A
Experimental
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Intervention: AZD5148 (Drug)
Outcomes
Primary Outcomes
First occurrence of recurrence of C difficile infection
Time Frame: Day 1 through day 91
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.
Secondary Outcomes
- 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)
- Severity of participant reported diarrhea symptoms(Day 1 through Day 91)
- First occurrence of fulminant recurrent C difficile infection(Day 1 through Day 91)
- Duration of participant reported diarrhea symptoms(Day 1 through Day 91)
- Occurrence of recurrent C difficile related mortality(Day 1 through Day 91)
- Immediate adverse events(1 hour post-IMP administration)
- Injection/Infusion-related reactions(24 hours post-IMP administration)
- Local reactions at the injection/infusion site(Day 1 through Day 8)
- Serious adverse events(ICF date through Day 361)
- Related adverse events(Day 1 through Day 361)
- Adverse events(Day 1 through Day 91)
- Medically attended adverse events (MAAEs)(Day 1 through Day 361)
- Adverse events of special interest (AESIs)(Day 1 through Day 361)
- Pharmacokinetics of AZD5148(Day 1 through Day 361)
- Anti-drug antibodies to AZD5148(Day 1 through Day 361)
Investigators
Study Sites (138)
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