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Estudio de Prevención de Infección Recurrente por C. Difficile con Anticuerpo Monoclonal AZD5148 (PRISM)

9 de noviembre de 2026 actualizado por: AstraZeneca

Un estudio de fase IIb, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de AZD5148 en la prevención de la recurrencia de la infección por Clostridioides difficile en individuos de 18 años de edad o más

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

230

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Augsburg, Alemania, 86156
        • Reclutamiento
        • Research Site
      • Berlin, Alemania, 13353
        • Reclutamiento
        • Research Site
      • Cologne, Alemania, 50937
        • Reclutamiento
        • Research Site
      • Frankfurt, Alemania, 60590
        • Reclutamiento
        • Research Site
      • Hamburg, Alemania, 20246
        • Reclutamiento
        • Research Site
      • Jena, Alemania, 07747
        • Retirado
        • Research Site
      • Leipzig, Alemania, 04103
        • Reclutamiento
        • Research Site
      • München, Alemania, 81675
        • Reclutamiento
        • Research Site
  • Australia
      • Camperdown, Australia, 2050
        • Reclutamiento
        • Research Site
      • Clayton, Australia, 3168
        • Reclutamiento
        • Research Site
      • Herston, Australia, 4029
        • Reclutamiento
        • Research Site
      • Melbourne, Australia, 3000
        • Reclutamiento
        • Research Site
      • South Brisbane, Australia, 4101
        • Reclutamiento
        • Research Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2X8
        • Retirado
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • Reclutamiento
        • Research Site
      • Victoria, British Columbia, Canadá, V8T 5G4
        • Retirado
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3K 6R8
        • Reclutamiento
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 4A6
        • Aún no reclutando
        • Research Site
      • London, Ontario, Canadá, N6A 5A5
        • Reclutamiento
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H4A 3S5
        • Reclutamiento
        • Research Site
      • Québec, Quebec, Canadá, G1V 4T3
        • Reclutamiento
        • Research Site
      • Sherbrooke, Quebec, Canadá, J1H 5N4
        • Reclutamiento
        • Research Site
  • Dinamarca
      • Aarhus N, Dinamarca, 8200
        • Reclutamiento
        • Research Site
      • Gistrup, Dinamarca, 9260
        • Reclutamiento
        • Research Site
      • Hvidovre, Dinamarca, 2650
        • Reclutamiento
        • Research Site
      • København Ø, Dinamarca, 2100
        • Reclutamiento
        • Research Site
      • Odense C, Dinamarca, 5000
        • Reclutamiento
        • Research Site
  • España
      • Alicante, España, 03010
        • Reclutamiento
        • Research Site
      • Badalona, España, 08916
        • Reclutamiento
        • Research Site
      • Madrid, España, 28007
        • Reclutamiento
        • Research Site
      • Madrid, España, 28034
        • Reclutamiento
        • Research Site
      • Madrid, España, 28040
        • Reclutamiento
        • Research Site
      • Madrid, España, 28046
        • Reclutamiento
        • Research Site
      • Majadahonda, España, 28220
        • Reclutamiento
        • Research Site
      • Seville, España, 41009
        • Reclutamiento
        • Research Site
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85032
        • Retirado
        • Research Site
    • California
      • Chula Vista, California, Estados Unidos, 91911
        • Retirado
        • Research Site
      • Sacramento, California, Estados Unidos, 95817
        • Reclutamiento
        • Research Site
      • Torrance, California, Estados Unidos, 90502
        • Reclutamiento
        • Research Site
    • Connecticut
      • Hamden, Connecticut, Estados Unidos, 06518
        • Reclutamiento
        • Research Site
    • Florida
      • Gainesville, Florida, Estados Unidos, 32605
        • Retirado
        • Research Site
      • Hialeah, Florida, Estados Unidos, 33016
        • Reclutamiento
        • Research Site
      • Homestead, Florida, Estados Unidos, 33033
        • Reclutamiento
        • Research Site
      • Jacksonville, Florida, Estados Unidos, 32256
        • Reclutamiento
        • Research Site
      • Miami Lakes, Florida, Estados Unidos, 33014
        • Retirado
        • Research Site
      • Miramar, Florida, Estados Unidos, 33027
        • Retirado
        • Research Site
      • Port Orange, Florida, Estados Unidos, 32127
        • Retirado
        • Research Site
      • Tamarac, Florida, Estados Unidos, 33321
        • Retirado
        • Research Site
      • Tampa, Florida, Estados Unidos, 33607
        • Retirado
        • Research Site
    • Georgia
      • Athens, Georgia, Estados Unidos, 30606
        • Reclutamiento
        • Research Site
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Reclutamiento
        • Research Site
    • Illinois
      • Burr Ridge, Illinois, Estados Unidos, 60527
        • Reclutamiento
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
        • Retirado
        • Research Site
      • Louisville, Kentucky, Estados Unidos, 40202
        • Reclutamiento
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Reclutamiento
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, Estados Unidos, 21061
        • Reclutamiento
        • Research Site
      • Potomac, Maryland, Estados Unidos, 20854
        • Reclutamiento
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Research Site
      • Boston, Massachusetts, Estados Unidos, 02115
        • Reclutamiento
        • Research Site
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Research Site
      • Royal Oak, Michigan, Estados Unidos, 48073
        • Reclutamiento
        • Research Site
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
        • Reclutamiento
        • Research Site
      • Kansas City, Missouri, Estados Unidos, 64114
        • Reclutamiento
        • Research Site
      • St Louis, Missouri, Estados Unidos, 63130
        • Reclutamiento
        • Research Site
    • New Jersey
      • Union City, New Jersey, Estados Unidos, 07087
        • Reclutamiento
        • Research Site
    • New York
      • Hartsdale, New York, Estados Unidos, 10530
        • Retirado
        • Research Site
      • Inwood, New York, Estados Unidos, 11096
        • Retirado
        • Research Site
      • The Bronx, New York, Estados Unidos, 10451
        • Retirado
        • Research Site
    • North Carolina
      • Salisbury, North Carolina, Estados Unidos, 28144
        • Reclutamiento
        • Research Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Reclutamiento
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15237
        • Retirado
        • Research Site
    • Tennessee
      • Johnson City, Tennessee, Estados Unidos, 37614
        • Reclutamiento
        • Research Site
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Reclutamiento
        • Research Site
      • Lynchburg, Virginia, Estados Unidos, 24501
        • Reclutamiento
        • Research Site
      • Roanoke, Virginia, Estados Unidos, 24014
        • Reclutamiento
        • Research Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98109
        • Reclutamiento
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • Aún no reclutando
        • Research Site
  • Francia
      • Lyon, Francia, 69317
        • Reclutamiento
        • Research Site
      • Montpellier, Francia, 34295
        • Reclutamiento
        • Research Site
      • Nantes, Francia, 44093
        • Reclutamiento
        • Research Site
      • Nîmes, Francia, 30029
        • Reclutamiento
        • Research Site
      • Paris, Francia, 75014
        • Reclutamiento
        • Research Site
      • Paris, Francia, 75475
        • Reclutamiento
        • Research Site
      • Tours, Francia, 37044
        • Reclutamiento
        • Research Site
  • Grecia
      • Athens, Grecia, 12462
        • Reclutamiento
        • Research Site
      • Athens, Grecia, 11527
        • Reclutamiento
        • Research Site
      • Heraklion, Grecia, 71500
        • Reclutamiento
        • Research Site
      • Ioannina, Grecia, 45500
        • Reclutamiento
        • Research Site
      • Thessaloniki, Grecia, 57010
        • Reclutamiento
        • Research Site
  • Hungría
      • Budapest, Hungría, 1082
        • Reclutamiento
        • Research Site
      • Debrecen, Hungría, 4031
        • Reclutamiento
        • Research Site
      • Eger, Hungría, 3300
        • Reclutamiento
        • Research Site
      • Kistarcsa, Hungría, 2143
        • Reclutamiento
        • Research Site
      • Pécs, Hungría, 7624
        • Reclutamiento
        • Research Site
  • Italia
      • Modena, Italia, 41124
        • Reclutamiento
        • Research Site
      • Naples, Italia, 80131
        • Reclutamiento
        • Research Site
      • Palermo, Italia, 90127
        • Reclutamiento
        • Research Site
      • Pisa, Italia, 56124
        • Reclutamiento
        • Research Site
      • Roma, Italia, 00161
        • Retirado
        • Research Site
      • Varese, Italia, 21100
        • Reclutamiento
        • Research Site
  • Japón
      • Kochi, Japón, 780-8522
        • Reclutamiento
        • Research Site
      • Kumamoto, Japón, 861-8520
        • Reclutamiento
        • Research Site
      • Meguro-ku, Japón, 153-0051
        • Reclutamiento
        • Research Site
      • Nagasaki, Japón, 852-8501
        • Reclutamiento
        • Research Site
      • Shimonoseki-shi, Japón, 750-8520
        • Reclutamiento
        • Research Site
      • Yaizu-shi, Japón, 425-8505
        • Reclutamiento
        • Research Site
  • Polonia
      • Lublin, Polonia, 20-081
        • Retirado
        • Research Site
      • Warsaw, Polonia, 04-141
        • Retirado
        • Research Site
  • Reino Unido
      • Birmingham, Reino Unido, B15 2TH
        • Reclutamiento
        • Research Site
      • Cambridge, Reino Unido, CB2 0QQ
        • Reclutamiento
        • Research Site
      • Cardiff, Reino Unido, CF14 4XW
        • Reclutamiento
        • Research Site
      • Newcastle, Reino Unido, NE14LP
        • Reclutamiento
        • Research Site
  • Suecia
      • Helsingborg, Suecia, 25187
        • Retirado
        • Research Site
      • Lund, Suecia, 22185
        • Reclutamiento
        • Research Site
      • Malmö, Suecia, 20502
        • Reclutamiento
        • Research Site
      • Västerås, Suecia, 72189
        • Reclutamiento
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AZD5148: dose A

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

Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Comparador de placebos: Placebo

Participants will receive a single dose of placebo via intramuscular or intravenous push.
Otro: Placebo

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
First occurrence of recurrence of C difficile infection
Periodo de tiempo: Day 1 through day 91

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.
Day 1 through day 91

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sustained clinical cure
Periodo de tiempo: Day 91

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.
Day 91
Duration of recurrent C difficile infection
Periodo de tiempo: Day 1 through Day 91

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.
Day 1 through Day 91
First occurrence of severe recurrent C difficile infection
Periodo de tiempo: Day 1 through Day 91

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.
Day 1 through Day 91
First occurrence of fulminant recurrent C difficile infection
Periodo de tiempo: Day 1 through Day 91

Fulminant rCDI is defined as a severe rCDI event with hypotension or shock, toxic megacolon, or ileus.
Day 1 through Day 91
Severity of participant reported diarrhea symptoms
Periodo de tiempo: Day 1 through Day 91

As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.
Day 1 through Day 91
Duration of participant reported diarrhea symptoms
Periodo de tiempo: Day 1 through Day 91

As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.
Day 1 through Day 91
First occurrence of hospitalization due to recurrent C difficile infection
Periodo de tiempo: Day 1 through Day 91

Hospitalization due to rCDI is defined as a confirmed rCDI event and a hospitalization related to the rCDI event.
Day 1 through Day 91
Duration of hospitalizations due to recurrent C difficile infection
Periodo de tiempo: Day 1 though Day 91

The sum of all hospitalization durations related to the first recurrent CDI that leads to hospitalization.
Day 1 though Day 91
Occurrence of recurrent C difficile related mortality
Periodo de tiempo: Day 1 through Day 91

rCDI related mortality is defined as a death related to rCDI as assessed by the Investigator.
Day 1 through Day 91
Immediate adverse events
Periodo de tiempo: 1 hour post-IMP administration

Adverse events with a start time within 1 hour post-IMP administration
1 hour post-IMP administration
Injection/Infusion-related reactions
Periodo de tiempo: 24 hours post-IMP administration

Injection or infusion-related reactions with a start date and time within 24 hours of IMP administration.
24 hours post-IMP administration
Local reactions at the injection/infusion site
Periodo de tiempo: Day 1 through Day 8

Local reactions at the injection or infusion site with a start date through Day 8 post-IMP administration.
Day 1 through Day 8
Serious adverse events
Periodo de tiempo: ICF date through Day 361

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)
ICF date through Day 361
Medically attended adverse events (MAAEs)
Periodo de tiempo: Day 1 through Day 361

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.
Day 1 through Day 361
Adverse events of special interest (AESIs)
Periodo de tiempo: Day 1 through Day 361

AESIs as defined by Clinical Study Protocol.
Day 1 through Day 361
Related adverse events
Periodo de tiempo: Day 1 through Day 361

Related AEs are adverse events assessed as related to IMP by the Investigator.
Day 1 through Day 361
Adverse events
Periodo de tiempo: Day 1 through Day 91

AEs are defined as any unfavourable medical occurrence in a participant administered the IMP, regardless of the causal relationship to IMP.
Day 1 through Day 91
Pharmacokinetics of AZD5148
Periodo de tiempo: Day 1 through Day 361

PK will be characterized through AZD5148 serum concentrations over time in participants who receive AZD5148.
Day 1 through Day 361
Anti-drug antibodies to AZD5148
Periodo de tiempo: Day 1 through Day 361

Immunogenicity is evaluated through AZD5148 anti-drug antibody responses over time in serum from participants who receive AZD5148.
Day 1 through Day 361

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de diciembre de 2025

Finalización primaria (Estimado)

20 de abril de 2027

Finalización del estudio (Estimado)

18 de enero de 2028

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2025

Publicado por primera vez (Actual)

16 de diciembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D8820C00003

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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