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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• First occurrence of recurrence of C difficile infection [Срок оценки: Day 1 through day 91]

Вторичные конечные точки (12)

• Sustained clinical cure [Срок оценки: Day 91]
• Duration of recurrent C difficile infection [Срок оценки: Day 1 through Day 91]
• First occurrence of severe recurrent C difficile infection [Срок оценки: Day 1 through Day 91]
• First occurrence of fulminant recurrent C difficile infection [Срок оценки: Day 1 through Day 91]
• Severity of participant reported diarrhea symptoms [Срок оценки: Day 1 through Day 91]
• Duration of participant reported diarrhea symptoms [Срок оценки: Day 1 through Day 91]
• First occurrence of hospitalization due to recurrent C difficile infection [Срок оценки: Day 1 through Day 91]
• Duration of hospitalizations due to recurrent C difficile infection [Срок оценки: Day 1 though Day 91]
• Occurrence of recurrent C difficile related mortality [Срок оценки: Day 1 through Day 91]
• Immediate adverse events [Срок оценки: 1 hour post-IMP administration]
• Injection/Infusion-related reactions [Срок оценки: 24 hours post-IMP administration]
• Local reactions at the injection/infusion site [Срок оценки: Day 1 through Day 8]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 42 центра

• Research Site — Phoenix
• Research Site — Chula Vista
• Research Site — Sacramento
• Research Site — Torrance
• Research Site — Hamden
• Research Site — Gainesville
• Research Site — Hialeah
• Research Site — Homestead
• … и ещё 34 центра

Канада · 9 центров

• Research Site — Edmonton
• Research Site — Vancouver
• Research Site — Victoria
• Research Site — Halifax
• Research Site — Hamilton
• Research Site — London
• Research Site — Montreal
• Research Site — Québec
• … и ещё 1 центр

Германия · 8 центров

• Research Site — Augsburg
• Research Site — Berlin
• Research Site — Cologne
• Research Site — Frankfurt
• Research Site — Hamburg
• Research Site — Jena
• Research Site — Leipzig
• Research Site — München

Испания · 8 центров

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Франция · 7 центров

• Research Site — Lyon
• Research Site — Montpellier
• Research Site — Nantes
• Research Site — Nîmes
• Research Site — Paris
• Research Site — Paris
• Research Site — Tours

Италия · 6 центров

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Япония · 6 центров

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Австралия · 5 центров

• Research Site — Camperdown
• Research Site — Clayton
• Research Site — Herston
• Research Site — Melbourne
• Research Site — South Brisbane

Дания · 5 центров

• Research Site — Aarhus N
• Research Site — Gistrup
• Research Site — Hvidovre
• Research Site — København Ø
• Research Site — Odense C

Греция · 5 центров

• Research Site — Athens
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• Research Site — Heraklion
• Research Site — Ioannina
• … и ещё 1 центр

Венгрия · 5 центров

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Швеция · 4 центра

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Великобритания · 4 центра

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Польша · 2 центра

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Идентификаторы

NCT: NCT07285213 · D8820C00003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗