At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD5148 (drug), Placebo (other)
- How long the study runs
- Study runs about 25 months (dates as stated)
- About the drug or intervention
- AZD5148 — drug: Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push. · Placebo — other: Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 230
- Started
- 2025-12-10
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for clostridioides difficile infection
- • Phase2 - 230 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with clostridioides difficile infection
Where?
- • Birmingham - Research Site
- • Cambridge - Research Site
- • Cardiff - Research Site
- • Newcastle - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ to be present on the day of IMP administration) and
What the study is looking for
- ✓Participant must be ≥ 18 years of age at the time of signing the agreement to take part, capable of giving signed informed...
- ✓Participants with a qualifying C. difficile infection episode at the time of providing agreement to take part defined by:
- ✓History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days,...
- ✓Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or...
- ✓Body weight ≥ 35 kg
Who cannot take part
- ✗Participants with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose...
- ✗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...
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
Birmingham B15 2TH, United Kingdom
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Cardiff CF14 4XW, United Kingdom
Research Site
Newcastle NE14LP, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
