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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
230
Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
Participants will receive a single dose of placebo (0.9% (w/v) sodium chloride for injection) administered via either intramuscular injection or intravenous push.
First occurrence of recurrence of C difficile infection
rCDI is a recurrence of C difficile infection (CDI) occurring after initial clinical cure of the qualifying 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.
Time frame: Day 1 through day 91
Sustained clinical cure
Sustained clinical cure is defined as achieving initial clinical cure (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 25 days of standard of care antibacterial drug therapy for CDI.
Time frame: Day 91
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.
Time frame: Day 1 through Day 91
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.
Time frame: Day 1 through Day 91
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.
Time frame: Day 1 through Day 91
AstraZeneca Clinical Study Information Center
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Research Site
Phoenix, Arizona, United States
WITHDRAWNResearch Site
Chula Vista, California, United States
WITHDRAWNResearch Site
Sacramento, California, United States
NOT_YET_RECRUITINGResearch Site
Torrance, California, United States
NOT_YET_RECRUITINGResearch Site
Hamden, Connecticut, United States
RECRUITINGResearch Site
Gainesville, Florida, United States
RECRUITINGResearch Site
Homestead, Florida, United States
RECRUITINGResearch Site
Jacksonville, Florida, United States
RECRUITINGResearch Site
Miami Lakes, Florida, United States
WITHDRAWNResearch Site
Miramar, Florida, United States
NOT_YET_RECRUITING...and 100 more locations
Severity of participant reported diarrhea symptoms
As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.
Time frame: Day 1 through Day 91
Duration of participant reported diarrhea symptoms
As reported by patient reported outcome (PRO) instrument for first occurrence of rCDI.
Time frame: Day 1 through Day 91
Occurrence of recurrent C difficile related mortality
rCDI related mortality is defined as a death related to rCDI as assessed by the Investigator.
Time frame: Day 1 through Day 91
Immediate adverse events
Adverse events with a start time within 1 hour post-IMP administration
Time frame: 1 hour post-IMP administration
Injection/Infusion-related reactions
Injection or infusion-related reactions with a start date and time within 24 hours of IMP administration.
Time frame: 24 hours post-IMP administration
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.
Time frame: Day 1 through Day 8
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)
Time frame: ICF date through Day 361
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.
Time frame: Day 1 through Day 361
Adverse events of special interest (AESIs)
AESIs as defined by Clinical Study Protocol.
Time frame: Day 1 through Day 361
Related adverse events
Related AEs are adverse events assessed as related to IMP by the Investigator.
Time frame: Day 1 through Day 361
Adverse events
AEs are defined as any unfavourable medical occurrence in a participant administered the IMP, regardless of the causal relationship to IMP.
Time frame: Day 1 through Day 91
Pharmacokinetics of AZD5148
PK will be characterized through AZD5148 serum concentrations over time in participants who receive AZD5148.
Time frame: Day 1 through Day 361
Anti-drug antibodies to AZD5148
Immunogenicity is evaluated through AZD5148 anti-drug antibody responses over time in serum from participants who receive AZD5148.
Time frame: Day 1 through Day 361