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Can a single shot stop c. diff from returning?

NCT ID NCT07285213

Prevention Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests a new drug called AZD5148 to see if it can prevent repeat C. diff infections in adults. About 230 people will get either the drug or a placebo as a single injection. The goal is to stop the infection from coming back after standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD5148
What this could lead to
If it works, this could offer a new way to prevent C. diff infections from coming back, reducing repeat illness and hospital visits.
What could go wrong
This is an early Phase 2 trial with only 230 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridioides difficile infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    99 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Phoenix, Arizona, 85032, United States

  • Research Site

    WITHDRAWN

    Chula Vista, California, 91911, United States

  • Research Site

    RECRUITING

    Sacramento, California, 95817, United States

  • Research Site

    RECRUITING

    Torrance, California, 90502, United States

  • Research Site

    RECRUITING

    Hamden, Connecticut, 06518, United States

  • Research Site

    WITHDRAWN

    Gainesville, Florida, 32605, United States

  • Research Site

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Research Site

    RECRUITING

    Homestead, Florida, 33033, United States

  • Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Research Site

    WITHDRAWN

    Miami Lakes, Florida, 33014, United States

  • Research Site

    WITHDRAWN

    Miramar, Florida, 33027, United States

  • Research Site

    WITHDRAWN

    Port Orange, Florida, 32127, United States

  • Research Site

    WITHDRAWN

    Tamarac, Florida, 33321, United States

  • Research Site

    WITHDRAWN

    Tampa, Florida, 33607, United States

  • Research Site

    RECRUITING

    Athens, Georgia, 30606, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • Research Site

    RECRUITING

    Burr Ridge, Illinois, 60527, United States

  • Research Site

    RECRUITING

    Lexington, Kentucky, 40509, United States

  • Research Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Research Site

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Research Site

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Research Site

    RECRUITING

    Potomac, Maryland, 20854, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Research Site

    RECRUITING

    Columbia, Missouri, 65212, United States

  • Research Site

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64114, United States

  • Research Site

    NOT_YET_RECRUITING

    St Louis, Missouri, 63130, United States

  • Research Site

    RECRUITING

    Union City, New Jersey, 07087, United States

  • Research Site

    WITHDRAWN

    Hartsdale, New York, 10530, United States

  • Research Site

    WITHDRAWN

    Inwood, New York, 11096, United States

  • Research Site

    RECRUITING

    The Bronx, New York, 10451, United States

  • Research Site

    RECRUITING

    Salisbury, North Carolina, 28144, United States

  • Research Site

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Research Site

    WITHDRAWN

    Pittsburgh, Pennsylvania, 15237, United States

  • Research Site

    RECRUITING

    Johnson City, Tennessee, 37614, United States

  • Research Site

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Research Site

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • Research Site

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Research Site

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Research Site

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53705, United States

  • Research Site

    RECRUITING

    Camperdown, 2050, Australia

  • Research Site

    RECRUITING

    Clayton, 3168, Australia

  • Research Site

    RECRUITING

    Herston, 4029, Australia

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    RECRUITING

    South Brisbane, 4101, Australia

  • Research Site

    WITHDRAWN

    Edmonton, Alberta, T6G 2X8, Canada

  • Research Site

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Research Site

    WITHDRAWN

    Victoria, British Columbia, V8T 5G4, Canada

  • Research Site

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Research Site

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • Research Site

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3S5, Canada

  • Research Site

    RECRUITING

    Québec, Quebec, G1V 4T3, Canada

  • Research Site

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Research Site

    RECRUITING

    Aarhus N, 8200, Denmark

  • Research Site

    RECRUITING

    Gistrup, 9260, Denmark

  • Research Site

    RECRUITING

    Hvidovre, 2650, Denmark

  • Research Site

    RECRUITING

    København Ø, 2100, Denmark

  • Research Site

    RECRUITING

    Odense C, 5000, Denmark

  • Research Site

    RECRUITING

    Lyon, 69317, France

  • Research Site

    RECRUITING

    Montpellier, 34295, France

  • Research Site

    RECRUITING

    Nantes, 44093, France

  • Research Site

    RECRUITING

    Nîmes, 30029, France

  • Research Site

    RECRUITING

    Paris, 75014, France

  • Research Site

    RECRUITING

    Paris, 75475, France

  • Research Site

    RECRUITING

    Tours, 37044, France

  • Research Site

    RECRUITING

    Augsburg, 86156, Germany

  • Research Site

    RECRUITING

    Berlin, 13353, Germany

  • Research Site

    RECRUITING

    Cologne, 50937, Germany

  • Research Site

    RECRUITING

    Frankfurt, 60590, Germany

  • Research Site

    RECRUITING

    Hamburg, 20246, Germany

  • Research Site

    WITHDRAWN

    Jena, 07747, Germany

  • Research Site

    RECRUITING

    Leipzig, 04103, Germany

  • Research Site

    RECRUITING

    München, 81675, Germany

  • Research Site

    RECRUITING

    Athens, 11527, Greece

  • Research Site

    RECRUITING

    Athens, 12462, Greece

  • Research Site

    RECRUITING

    Heraklion, 71500, Greece

  • Research Site

    RECRUITING

    Ioannina, 45500, Greece

  • Research Site

    RECRUITING

    Thessaloniki, 57010, Greece

  • Research Site

    RECRUITING

    Budapest, 1082, Hungary

  • Research Site

    RECRUITING

    Debrecen, 4031, Hungary

  • Research Site

    RECRUITING

    Eger, 3300, Hungary

  • Research Site

    RECRUITING

    Kistarcsa, 2143, Hungary

  • Research Site

    RECRUITING

    Pécs, 7624, Hungary

  • Research Site

    NOT_YET_RECRUITING

    Modena, 41124, Italy

  • Research Site

    RECRUITING

    Naples, 80131, Italy

  • Research Site

    RECRUITING

    Palermo, 90127, Italy

  • Research Site

    RECRUITING

    Pisa, 56124, Italy

  • Research Site

    WITHDRAWN

    Roma, 00161, Italy

  • Research Site

    RECRUITING

    Varese, 21100, Italy

  • Research Site

    RECRUITING

    Kochi, 780-8522, Japan

  • Research Site

    RECRUITING

    Kumamoto, 861-8520, Japan

  • Research Site

    RECRUITING

    Meguro-ku, 153-0051, Japan

  • Research Site

    RECRUITING

    Nagasaki, 852-8501, Japan

  • Research Site

    RECRUITING

    Shimonoseki-shi, 750-8520, Japan

  • Research Site

    RECRUITING

    Yaizu-shi, 425-8505, Japan

  • Research Site

    WITHDRAWN

    Lublin, 20-081, Poland

  • Research Site

    WITHDRAWN

    Warsaw, 04-141, Poland

  • Research Site

    RECRUITING

    Alicante, 03010, Spain

  • Research Site

    RECRUITING

    Badalona, 08916, Spain

  • Research Site

    RECRUITING

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Madrid, 28046, Spain

  • Research Site

    RECRUITING

    Majadahonda, 28220, Spain

  • Research Site

    RECRUITING

    Seville, 41009, Spain

  • Research Site

    WITHDRAWN

    Helsingborg, 25187, Sweden

  • Research Site

    RECRUITING

    Lund, 22185, Sweden

  • Research Site

    RECRUITING

    Malmö, 20502, Sweden

  • Research Site

    RECRUITING

    Västerås, 72189, Sweden

  • Research Site

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Research Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Newcastle, NE14LP, United Kingdom

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