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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07285213
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clostridioides Difficile Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Jun 2026
Primary completion
Apr 20, 2027
Completion
Jan 18, 2028

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: AZD5148: dose A
    Participants will receive a single dose A of AZD5148 administered via either intramuscular injection or intravenous push.
  • Placebo Comparator: Placebo
    Participants will receive a single dose of placebo via intramuscular or intravenous push.

Primary Outcome Measure

First occurrence of recurrence of C difficile infection [ Time Frame: Day 1 through day 91 ]

Central Contacts

Locations (42)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85032-
Research SiteChula VistaCalifornia91911-
Research SiteSacramentoCalifornia95817-
Research SiteTorranceCalifornia90502-
Research SiteHamdenConnecticut06518-
Research SiteGainesvilleFlorida32605-
Research SiteHialeahFlorida33016-
Research SiteHomesteadFlorida33033-
Research SiteJacksonvilleFlorida32256-
Research SiteMiami LakesFlorida33014-
Research SiteMiramarFlorida33027-
Research SitePort OrangeFlorida32127-
Research SiteTamaracFlorida33321-
Research SiteTampaFlorida33607-
Research SiteAthensGeorgia30606-
Research SiteAtlantaGeorgia30322-
Research SiteIdaho FallsIdaho83404-
Research SiteBurr RidgeIllinois60527-
Research SiteLexingtonKentucky40509-
Research SiteLouisvilleKentucky40202-
Research SiteNew OrleansLouisiana70121-
Research SiteGlen BurnieMaryland21061-
Research SitePotomacMaryland20854-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteDetroitMichigan48202-
Research SiteRoyal OakMichigan48073-
Research SiteColumbiaMissouri65212-
Research SiteSt LouisMissouri63130-
Research SiteUnion CityNew Jersey07087-
Research SiteHartsdaleNew York10530-
Research SiteInwoodNew York11096-
Research SiteThe BronxNew York10451-
Research SiteSalisburyNorth Carolina28144-
Research SiteWinston-SalemNorth Carolina27103-
Research SitePittsburghPennsylvania15237-
Research SiteJohnson CityTennessee37614-
Research SiteCharlottesvilleVirginia22903-
Research SiteLynchburgVirginia24501-
Research SiteRoanokeVirginia24014-
Research SiteSeattleWashington98109-
Research SiteMadisonWisconsin53705-

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