Table of contents
Overview of the study
The available trial is a Phase 2 study that looks at whether HUMANISED IGG1 KAPPA (YTE) MONOCLONAL ANTIBODY AGAINST CLOSTRIDIOIDES DIFFICILE, TOXIN B can help prevent recurrent Clostridioides difficile infection.[1]
The study is Authorised and includes 259 participants.[1]
It is an interventional trial, which means researchers give a treatment and compare outcomes between study groups.[1]
Who the study is for
This study focuses on people with recurrence of Clostridioides difficile infection, meaning the infection has come back after previous treatment.[1]
The trial summary says the treatment is given during standard of care antibacterial drug therapy for C. difficile infection.[1]
No further details about age limits, sex, or other entry rules are given in the source information provided here.[1]
How the study is designed
The study compares HUMANISED IGG1 KAPPA (YTE) MONOCLONAL ANTIBODY AGAINST CLOSTRIDIOIDES DIFFICILE, TOXIN B with placebo, which is a control treatment without active effect.[1]
The brief summary says the treatment is planned as a single dose and may be given by intramuscular or intravenous route, but the intervention list in the trial record specifically mentions intravenous infusion for AZD5148.[1]
The study is designed to see whether the treatment can lower the chance of recurrence compared with placebo through Day 91.[1]
What the study measures
The primary outcome is the first occurrence of recurrent C. difficile infection.[1]
This means the researchers are mainly checking whether a new episode of infection happens after treatment.[1]
The trial summary also shows that the key time window is up to Day 91.[1]
