Back to Trials
NCT07285213PHASE2Recruiting

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

AstraZeneca

Start Date

12/10/2025

Completion Date

1/18/2028

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AZD5148

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Clostridioides Difficile Infection

Locations

Research Site

Phoenix, Arizona 85032

United States

Research Site

Chula Vista, California 91911

United States

Research Site

Sacramento, California 95817

United States

Research Site

Torrance, California 90502

United States

Research Site

Hamden, Connecticut 06518

United States

Research Site

Gainesville, Florida 32605

United States

Research Site

Hialeah, Florida 33016

United States

Research Site

Homestead, Florida 33033

United States

Research Site

Jacksonville, Florida 32256

United States

Research Site

Miami Lakes, Florida 33014

United States

Research Site

Miramar, Florida 33027

United States

Research Site

Port Orange, Florida 32127

United States

Research Site

Tamarac, Florida 33321

United States

Research Site

Tampa, Florida 33607

United States

Research Site

Athens, Georgia 30606

United States

Research Site

Atlanta, Georgia 30322

United States

Research Site

Idaho Falls, Idaho 83404

United States

Research Site

Burr Ridge, Illinois 60527

United States

Research Site

Lexington, Kentucky 40509

United States

Research Site

Louisville, Kentucky 40202

United States

Research Site

New Orleans, Louisiana 70121

United States

Research Site

Glen Burnie, Maryland 21061

United States

Research Site

Potomac, Maryland 20854

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Boston, Massachusetts 02115

United States

Research Site

Detroit, Michigan 48202

United States

Research Site

Royal Oak, Michigan 48073

United States

Research Site

Columbia, Missouri 65212

United States

Research Site

St Louis, Missouri 63130

United States

Research Site

Union City, New Jersey 07087

United States

Research Site

Hartsdale, New York 10530

United States

Research Site

Inwood, New York 11096

United States

Research Site

The Bronx, New York 10451

United States

Research Site

Salisbury, North Carolina 28144

United States

Research Site

Winston-Salem, North Carolina 27103

United States

Research Site

Pittsburgh, Pennsylvania 15237

United States

Research Site

Johnson City, Tennessee 37614

United States

Research Site

Charlottesville, Virginia 22903

United States

Research Site

Lynchburg, Virginia 24501

United States

Research Site

Roanoke, Virginia 24014

United States

Research Site

Seattle, Washington 98109

United States

Research Site

Madison, Wisconsin 53705

United States

Research Site

Camperdown, 2050

Australia

Research Site

Clayton, 3168

Australia

Research Site

Herston, 4029

Australia

Research Site

Melbourne, 3000

Australia

Research Site

South Brisbane, 4101

Australia

Research Site

Edmonton, Alberta T6G 2X8

Canada

Research Site

Vancouver, British Columbia V5Z 1M9

Canada

Research Site

Victoria, British Columbia V8T 5G4

Canada

Research Site

Halifax, Nova Scotia B3K 6R8

Canada

Research Site

Hamilton, Ontario L8N 4A6

Canada

Research Site

London, Ontario N6A 5A5

Canada

Research Site

Montreal, Quebec H4A 3S5

Canada

Research Site

Québec, Quebec G1V 4T3

Canada

Research Site

Sherbrooke, Quebec J1H 5N4

Canada

Research Site

Aarhus N, 8200

Denmark

Research Site

Gistrup, 9260

Denmark

Research Site

Hvidovre, 2650

Denmark

Research Site

København Ø, 2100

Denmark

Research Site

Odense C, 5000

Denmark

Research Site

Lyon, 69317

France

Research Site

Montpellier, 34295

France

Research Site

Nantes, 44093

France

Research Site

Nîmes, 30029

France

Research Site

Paris, 75014

France

Research Site

Paris, 75475

France

Research Site

Tours, 37044

France

Research Site

Augsburg, 86156

Germany

Research Site

Berlin, 13353

Germany

Research Site

Cologne, 50937

Germany

Research Site

Frankfurt, 60590

Germany

Research Site

Hamburg, 20246

Germany

Research Site

Jena, 07747

Germany

Research Site

Leipzig, 04103

Germany

Research Site

München, 81675

Germany

Research Site

Athens, 11527

Greece

Research Site

Athens, 12462

Greece

Research Site

Heraklion, 71500

Greece

Research Site

Ioannina, 45500

Greece

Research Site

Thessaloniki, 57010

Greece

Research Site

Budapest, 1082

Hungary

Research Site

Debrecen, 4031

Hungary

Research Site

Eger, 3300

Hungary

Research Site

Kistarcsa, 2143

Hungary

Research Site

Pécs, 7624

Hungary

Research Site

Modena, 41124

Italy

Research Site

Naples, 80131

Italy

Research Site

Palermo, 90127

Italy

Research Site

Pisa, 56124

Italy

Research Site

Roma, 00161

Italy

Research Site

Varese, 21100

Italy

Research Site

Kochi, 780-8522

Japan

Research Site

Kumamoto, 861-8520

Japan

Research Site

Meguro-ku, 153-0051

Japan

Research Site

Nagasaki, 852-8501

Japan

Research Site

Shimonoseki-shi, 750-8520

Japan

Research Site

Yaizu-shi, 425-8505

Japan

Research Site

Lublin, 20-081

Poland

Research Site

Warsaw, 04-141

Poland

Research Site

Alicante, 03010

Spain

Research Site

Badalona, 08916

Spain

Research Site

Madrid, 28007

Spain

Research Site

Madrid, 28034

Spain

Research Site

Madrid, 28040

Spain

Research Site

Madrid, 28046

Spain

Research Site

Majadahonda, 28220

Spain

Research Site

Seville, 41009

Spain

Research Site

Helsingborg, 25187

Sweden

Research Site

Lund, 22185

Sweden

Research Site

Malmö, 20502

Sweden

Research Site

Västerås, 72189

Sweden

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