RecruitingNCT07285213ClinicalTrials.gov record

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

Clostridioides Difficile Infection

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 230 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Quadruple masked

AZD5148: dose A

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

Drug: AZD5148

Placebo

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

Other: Placebo

AZD5148 DRUG

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

Placebo OTHER

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

First occurrence of recurrence of C difficile infection

Time frame: 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.

Secondary measures

Sustained clinical cure

Time frame: 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.

Duration of recurrent C difficile infection

Time frame: 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.

First occurrence of severe recurrent C difficile infection

Time frame: 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.

First occurrence of fulminant recurrent C difficile infection

Time frame: Day 1 through Day 91

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

Severity of participant reported diarrhea symptoms

Time frame: Day 1 through Day 91

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

Duration of participant reported diarrhea symptoms

Time frame: Day 1 through Day 91

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

First occurrence of hospitalization due to recurrent C difficile infection

Time frame: Day 1 through Day 91

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

Duration of hospitalizations due to recurrent C difficile infection

Time frame: Day 1 though Day 91

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

Occurrence of recurrent C difficile related mortality

Time frame: Day 1 through Day 91

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

Immediate adverse events

Time frame: 1 hour post-IMP administration

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

Injection/Infusion-related reactions

Time frame: 24 hours post-IMP administration

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

Local reactions at the injection/infusion site

Time frame: Day 1 through Day 8

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

Serious adverse events

Time frame: 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)

Medically attended adverse events (MAAEs)

Time frame: 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.

Adverse events of special interest (AESIs)

Time frame: Day 1 through Day 361

AESIs as defined by Clinical Study Protocol.

Related adverse events

Time frame: Day 1 through Day 361

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

Adverse events

Time frame: 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.

Pharmacokinetics of AZD5148

Time frame: Day 1 through Day 361

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

Anti-drug antibodies to AZD5148

Time frame: Day 1 through Day 361

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (117)

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Find a location in this study

117 locations

Research SitePhoenix, Arizona, United StatesWithdrawn

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (117)

Study team and timeline

Official study contacts

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