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Looking for participantsPhase2

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

Sponsor: AstraZeneca

NCT ID: NCT07285213

View on ClinicalTrials.gov ↗

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.

Clostridioides Difficile Infection

How this trial compares with your answers

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What we know so far

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Still need:

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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
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: * 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, Note: At the time of randomization and IMP administration, the participant must have started receiving the antibacterial drug therapy with a planned total treatment duration of at least 10 and at most 28 days at time of IMP administration. IMP can be administered at any point during the antibacterial drug therapy. Body weight ≥ 35 kg Exclusion Criteria: Participants with a history of uncontrolled inflammatory bowel disease. Participants with a history of inflammatory bowel disease may be included if, in the opinion of the Investigator, their disease is clinically controlled and presenting symptoms are more likely attributable to CDI than to a flare of inflammatory bowel disease. Participants 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 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 28 days of antibacterial drug therapy for the qualifying C. difficile infection episode Participants receiving a fecal microbiota transplant, fecal microbiota product, or live biotherapeutic product for the qualifying CDI episode, 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.

Where Is This Study? (4 UK sites)

Research Site

Birmingham B15 2TH, United Kingdom

Recruiting

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Cardiff CF14 4XW, United Kingdom

NOT_YET_RECRUITING

Research Site

Newcastle NE14LP, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10