AzTrials
AzTrials

Clostridioides Difficile InfectionPhase 2PRISMNCT07285213

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

A Phase 2 study testing AZD5148 in people with Clostridioides Difficile Infection, run by AstraZeneca at 117 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clostridioides Difficile Infection
What is being tested?
AZD5148
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
117 sitesin 14 countries
Study dates
10 Dec 2025to 18 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

117 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

117 sites in 14 countries

United States43 sites, 32 recruiting

  • Research Site

    Athens, Georgia, 30606

    Recruiting

  • Research Site

    Atlanta, Georgia, 30322

    Recruiting

  • Research Site

    Boston, Massachusetts, 02114

    Recruiting

  • Research Site

    Boston, Massachusetts, 02115

    Recruiting

  • Research Site

    Burr Ridge, Illinois, 60527

    Recruiting

  • Research Site

    Charlottesville, Virginia, 22903

    Recruiting

  • Research Site

    Chula Vista, California, 91911

    Withdrawn

  • Research Site

    Columbia, Missouri, 65212

    Recruiting

  • Research Site

    Detroit, Michigan, 48202

    Recruiting

  • Research Site

    Gainesville, Florida, 32605

    Withdrawn

  • Research Site

    Glen Burnie, Maryland, 21061

    Recruiting

  • Research Site

    Hamden, Connecticut, 06518

    Recruiting

  • Research Site

    Hartsdale, New York, 10530

    Withdrawn

  • Research Site

    Hialeah, Florida, 33016

    Recruiting

  • Research Site

    Homestead, Florida, 33033

    Recruiting

  • Research Site

    Idaho Falls, Idaho, 83404

    Recruiting

  • Research Site

    Inwood, New York, 11096

    Withdrawn

  • Research Site

    Jacksonville, Florida, 32256

    Recruiting

  • Research Site

    Johnson City, Tennessee, 37614

    Recruiting

  • Research Site

    Kansas City, Missouri, 64114

    Not yet recruiting

  • Research Site

    Lexington, Kentucky, 40509

    Recruiting

  • Research Site

    Louisville, Kentucky, 40202

    Recruiting

  • Research Site

    Lynchburg, Virginia, 24501

    Recruiting

  • Research Site

    Madison, Wisconsin, 53705

    Not yet recruiting

  • Research Site

    Miami Lakes, Florida, 33014

    Withdrawn

  • Research Site

    Miramar, Florida, 33027

    Withdrawn

  • Research Site

    New Orleans, Louisiana, 70121

    Recruiting

  • Research Site

    Phoenix, Arizona, 85032

    Withdrawn

  • Research Site

    Pittsburgh, Pennsylvania, 15237

    Withdrawn

  • Research Site

    Port Orange, Florida, 32127

    Withdrawn

  • Research Site

    Potomac, Maryland, 20854

    Recruiting

  • Research Site

    Roanoke, Virginia, 24014

    Recruiting

  • Research Site

    Royal Oak, Michigan, 48073

    Recruiting

  • Research Site

    Sacramento, California, 95817

    Recruiting

  • Research Site

    Salisbury, North Carolina, 28144

    Recruiting

  • Research Site

    Seattle, Washington, 98109

    Not yet recruiting

  • Research Site

    St Louis, Missouri, 63130

    Not yet recruiting

  • Research Site

    Tamarac, Florida, 33321

    Withdrawn

  • Research Site

    Tampa, Florida, 33607

    Withdrawn

  • Research Site

    The Bronx, New York, 10451

    Recruiting

  • Research Site

    Torrance, California, 90502

    Recruiting

  • Research Site

    Union City, New Jersey, 07087

    Recruiting

  • Research Site

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

Canada9 sites, 7 recruiting

  • Research Site

    Edmonton, Alberta, T6G 2X8

    Withdrawn

  • Research Site

    Halifax, Nova Scotia, B3K 6R8

    Recruiting

  • Research Site

    Hamilton, Ontario, L8N 4A6

    Not yet recruiting

  • Research Site

    London, Ontario, N6A 5A5

    Recruiting

  • Research Site

    Montreal, Quebec, H4A 3S5

    Recruiting

  • Research Site

    Québec, Quebec, G1V 4T3

    Recruiting

  • Research Site

    Sherbrooke, Quebec, J1H 5N4

    Recruiting

  • Research Site

    Vancouver, British Columbia, V5Z 1M9

    Recruiting

  • Research Site

    Victoria, British Columbia, V8T 5G4

    Withdrawn

Other trials in Canada

Germany8 sites, 7 recruiting

  • Research Site

    Augsburg, 86156

    Recruiting

  • Research Site

    Berlin, 13353

    Recruiting

  • Research Site

    Cologne, 50937

    Recruiting

  • Research Site

    Frankfurt, 60590

    Recruiting

  • Research Site

    Hamburg, 20246

    Recruiting

  • Research Site

    Jena, 07747

    Withdrawn

  • Research Site

    Leipzig, 04103

    Recruiting

  • Research Site

    München, 81675

    Recruiting

Other trials in Germany

Spain8 sites, 8 recruiting

  • Research Site

    Alicante, 03010

    Recruiting

  • Research Site

    Badalona, 08916

    Recruiting

  • Research Site

    Madrid, 28007

    Recruiting

  • Research Site

    Madrid, 28034

    Recruiting

  • Research Site

    Madrid, 28040

    Recruiting

  • Research Site

    Madrid, 28046

    Recruiting

  • Research Site

    Majadahonda, 28220

    Recruiting

  • Research Site

    Seville, 41009

    Recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • Research Site

    Lyon, 69317

    Recruiting

  • Research Site

    Montpellier, 34295

    Recruiting

  • Research Site

    Nantes, 44093

    Recruiting

  • Research Site

    Nîmes, 30029

    Recruiting

  • Research Site

    Paris, 75014

    Recruiting

  • Research Site

    Paris, 75475

    Recruiting

  • Research Site

    Tours, 37044

    Recruiting

Other trials in France

Italy6 sites, 5 recruiting

  • Research Site

    Modena, 41124

    Not yet recruiting

  • Research Site

    Naples, 80131

    Recruiting

  • Research Site

    Palermo, 90127

    Recruiting

  • Research Site

    Pisa, 56124

    Recruiting

  • Research Site

    Roma, 00161

    Withdrawn

  • Research Site

    Varese, 21100

    Recruiting

Other trials in Italy

Japan6 sites, 6 recruiting

  • Research Site

    Kochi, 780-8522

    Recruiting

  • Research Site

    Kumamoto, 861-8520

    Recruiting

  • Research Site

    Meguro-ku, 153-0051

    Recruiting

  • Research Site

    Nagasaki, 852-8501

    Recruiting

  • Research Site

    Shimonoseki-shi, 750-8520

    Recruiting

  • Research Site

    Yaizu-shi, 425-8505

    Recruiting

Other trials in Japan

Australia5 sites, 5 recruiting

  • Research Site

    Camperdown, 2050

    Recruiting

  • Research Site

    Clayton, 3168

    Recruiting

  • Research Site

    Herston, 4029

    Recruiting

  • Research Site

    Melbourne, 3000

    Recruiting

  • Research Site

    South Brisbane, 4101

    Recruiting

Other trials in Australia

Denmark5 sites, 5 recruiting

  • Research Site

    Aarhus N, 8200

    Recruiting

  • Research Site

    Gistrup, 9260

    Recruiting

  • Research Site

    Hvidovre, 2650

    Recruiting

  • Research Site

    København Ø, 2100

    Recruiting

  • Research Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

Greece5 sites, 5 recruiting

  • Research Site

    Athens, 11527

    Recruiting

  • Research Site

    Athens, 12462

    Recruiting

  • Research Site

    Heraklion, 71500

    Recruiting

  • Research Site

    Ioannina, 45500

    Recruiting

  • Research Site

    Thessaloniki, 57010

    Recruiting

Other trials in Greece

Hungary5 sites, 5 recruiting

  • Research Site

    Budapest, 1082

    Recruiting

  • Research Site

    Debrecen, 4031

    Recruiting

  • Research Site

    Eger, 3300

    Recruiting

  • Research Site

    Kistarcsa, 2143

    Recruiting

  • Research Site

    Pécs, 7624

    Recruiting

Other trials in Hungary

Sweden4 sites, 3 recruiting

  • Research Site

    Helsingborg, 25187

    Withdrawn

  • Research Site

    Lund, 22185

    Recruiting

  • Research Site

    Malmö, 20502

    Recruiting

  • Research Site

    Västerås, 72189

    Recruiting

Other trials in Sweden

United Kingdom4 sites, 4 recruiting

  • Research Site

    Birmingham, B15 2TH

    Recruiting

  • Research Site

    Cambridge, CB2 0QQ

    Recruiting

  • Research Site

    Cardiff, CF14 4XW

    Not yet recruiting

  • Research Site

    Newcastle, NE14LP

    Recruiting

Other trials in United Kingdom

Poland2 sites

  • Research Site

    Lublin, 20-081

    Withdrawn

  • Research Site

    Warsaw, 04-141

    Withdrawn

Other trials in Poland

About this study

Official title: 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

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.

Read the 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.
Being tested
AZD5148, Placebo
Keywords
Clostridioides Difficile infection, C. Diff, CDiff, Clostridiodes Difficile Infection prevention of recurrence
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5148Drug

    Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.

  • PlaceboOther

    Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.

Study groups in NCT07285213
Study groupRoleWhat they receive
AZD5148: dose AExperimentalParticipants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Receives: Drug: AZD5148
PlaceboPlacebo comparatorParticipants will receive a single dose of placebo via intramuscular or intravenous push.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First occurrence of recurrence of C difficile infection

    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.

    Measured: Day 1 through day 91

Secondary outcomes (19)

  1. Sustained clinical cure

    Sustained clinical cure is defined as achieving ICC of the qualifying CDI and not having an rCDI event through Day 91. ICC is defined as clinical cure for the qualifying CDI episode with a duration of a minimum of 10 days and a maximum of 28 days of antibacterial drug therapy for CDI.

    Measured: Day 91

  2. Duration of recurrent C difficile infection

    Duration of the first occurrence of confirmed rCDI is calculated from the first day of diarrhea meeting the clinical symptom criteria until the date of clinical cure. Clinical cure is defined as <=2 unformed stools (ie, type 6 or 7 stool on Bristol Stool Scale) in 24 hours for 2 consecutive calendar days after the end of antibacterial drug treatment for the CDI episode.

    Measured: Day 1 through Day 91

  3. First occurrence of severe recurrent C difficile infection

    Severe rCDI is defined as an rCDI event characterized by either: peripheral blood leukocytosis with leukocyte count >15,000 cells/uL or serum creatinine level >1.5 mg/dL.

    Measured: Day 1 through Day 91

  4. First occurrence of fulminant recurrent C difficile infection

    Fulminant rCDI is defined as a severe rCDI event with hypotension or shock, toxic megacolon, or ileus.

    Measured: Day 1 through Day 91

  5. Severity of participant reported diarrhea symptoms

    As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.

    Measured: Day 1 through Day 91

  6. Duration of participant reported diarrhea symptoms

    As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.

    Measured: Day 1 through Day 91

  7. First occurrence of hospitalization due to recurrent C difficile infection

    Hospitalization due to rCDI is defined as a confirmed rCDI event and a hospitalization related to the rCDI event.

    Measured: Day 1 through Day 91

  8. Duration of hospitalizations due to recurrent C difficile infection

    The sum of all hospitalization durations related to the first recurrent CDI that leads to hospitalization.

    Measured: Day 1 though Day 91

  9. Occurrence of recurrent C difficile related mortality

    rCDI related mortality is defined as a death related to rCDI as assessed by the Investigator.

    Measured: Day 1 through Day 91

  10. Immediate adverse events

    Adverse events with a start time within 1 hour post-IMP administration

    Measured: 1 hour post-IMP administration

  11. Injection/Infusion-related reactions

    Injection or infusion-related reactions with a start date and time within 24 hours of IMP administration.

    Measured: 24 hours post-IMP administration

  12. Local reactions at the injection/infusion site

    Local reactions at the injection or infusion site with a start date through Day 8 post-IMP administration.

    Measured: Day 1 through Day 8

  13. Serious adverse events

    SAEs are adverse events that fulfill any of the SAE criteria and are recorded with a start date from the date of informed consent form signature until the end of the study follow-up (Day 361)

    Measured: ICF date through Day 361

  14. Medically attended adverse events (MAAEs)

    MAAEs are adverse events leading to medically attended visits that were not routine visits, such as ER visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

    Measured: Day 1 through Day 361

  15. Adverse events of special interest (AESIs)

    AESIs as defined by Clinical Study Protocol.

    Measured: Day 1 through Day 361

  16. Related adverse events

    Related AEs are adverse events assessed as related to IMP by the Investigator.

    Measured: Day 1 through Day 361

  17. Adverse events

    AEs are defined as any unfavourable medical occurrence in a participant administered the IMP, regardless of the causal relationship to IMP.

    Measured: Day 1 through Day 91

  18. Pharmacokinetics of AZD5148

    PK will be characterized through AZD5148 serum concentrations over time in participants who receive AZD5148.

    Measured: Day 1 through Day 361

  19. Anti-drug antibodies to AZD5148

    Immunogenicity is evaluated through AZD5148 anti-drug antibody responses over time in serum from participants who receive AZD5148.

    Measured: Day 1 through Day 361

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start10 Dec 2025
  3. Primary completion20 Apr 2027 (estimated)
  4. Study completion18 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285213
Sponsor's protocol ID
D8820C00003
Acronym
PRISM
Status last verified
Oct 2026
First submitted
20 Nov 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD5148 in people with Clostridioides Difficile Infection, run by AstraZeneca at 117 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Canada, Germany, Spain, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First occurrence of recurrence of C difficile infection (time frame: Day 1 through day 91). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07285213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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