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

RecruitingPhase 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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 230 · Started: Dec 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07285213

Locations in the U.S.

CaliforniaResearch Site, Sacramento
Research Site, Torrance
ConnecticutResearch Site, Hamden
FloridaResearch Site, Hialeah
Research Site, Homestead
Research Site, Jacksonville
GeorgiaResearch Site, Athens
Research Site, Atlanta
IdahoResearch Site, Idaho Falls
IllinoisResearch Site, Burr Ridge
KentuckyResearch Site, Lexington
Research Site, Louisville
LouisianaResearch Site, New Orleans
MarylandResearch Site, Glen Burnie
Research Site, Potomac
MassachusettsResearch Site, Boston
Research Site, Boston
MichiganResearch Site, Detroit
Research Site, Royal Oak
MissouriResearch Site, Columbia
Research Site, Kansas City (Not yet recruiting)
Research Site, St Louis (Not yet recruiting)
New JerseyResearch Site, Union City
New YorkResearch Site, The Bronx
North CarolinaResearch Site, Salisbury
Research Site, Winston-Salem
TennesseeResearch Site, Johnson City
VirginiaResearch Site, Charlottesville
Research Site, Lynchburg
Research Site, Roanoke
WashingtonResearch Site, Seattle (Not yet recruiting)
WisconsinResearch Site, Madison (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.