Trials / Recruiting
RecruitingNCT07285213
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD5148 | Participants will receive a single dose A of AZD5148 administered via either intramuscular injection 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. |
Timeline
- Start date
- 2025-12-10
- Primary completion
- 2027-04-20
- Completion
- 2028-01-18
- First posted
- 2025-12-16
- Last updated
- 2026-04-06
Locations
113 sites across 14 countries: United States, Australia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07285213. Inclusion in this directory is not an endorsement.