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Study for Preventing Recurrent C. Difficile Infection with AZD5148

This study is testing a drug called AZD5148 to see if it can prevent Clostridioides difficile (C. diff) infections from coming back. C. diff is a type of bacteria that can cause severe diarrhea. Participants will receive either a single dose of AZD5148 or a placebo (an inactive substance like saline solution) through an injection into a muscle or a vein. The main goal is to see if AZD5148 can reduce the chance of C. diff returning within 91 days. You may be able to join if you are 18 or older and have recently had a C. diff infection with specific symptoms. The study aims to enroll about 230 people, but its current recruitment status is unclear.

Study design
This is an interventional study where about 230 participants will be randomly assigned to receive either AZD5148 or a placebo in a 1:1 ratio.
What's involved
You would have up to 7 planned visits, including up to 2 for eligibility and dose administration. You would also complete an electronic diary and have weekly, then monthly, follow-up contacts initiated by site staff.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the first occurrence of C. difficile infection recurrence from Day 1 through Day 91 after treatment.

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NCT07285213

Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

Recruiting
PHASE2Ages 18+InterventionalPrevention
AstraZeneca
~230 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:AZD5148Placebo

At a glance

Recruiting sites
87 of 116 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
First occurrence of recurrence of C difficile infection
Measured over Day 1 through day 91

Conditions

Clostridioides Difficile Infection

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Clostridium difficile Infection

Where it's being run

116 sites across 38 states
Florida9
Germany8
Spain8
France7
Italy6
Japan6
Australia5
Denmark5

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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,

What this trial measures

  • First occurrence of recurrence of C difficile infectionDay 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.