Table of contents
- Trial overview
- Who can participate
- What is being measured
- Trial status and phase
- Study design and treatment groups
Trial overview
One authorised interventional trial is studying HUMANISED IGG1 KAPPA (YTE) MONOCLONAL ANTIBODY AGAINST CLOSTRIDIOIDES DIFFICILE, TOXIN B for recurrence of Clostridioides difficile infection.[1] The study is designed to see whether the treatment can lower the chance of the infection coming back after standard treatment.[1]
Who can participate
The source data says the trial is for people with recurrence of Clostridioides difficile infection.[1] It does not give more detailed inclusion rules such as age limits, lab values, or past treatment history.[1]
What is being measured
The main outcome is the first occurrence of recurrent C. difficile infection.[1] This means the researchers are checking whether a new episode happens after treatment, and they follow this through Day 91.[1]
Trial status and phase
This study is in Phase 2, which is a stage of research that usually looks more closely at whether a treatment may work while continuing to collect safety data.[1] The trial status is Authorised.[1]
Study design and treatment groups
The trial is interventional, meaning researchers assign the study treatment to participants.[1] The comparison includes placebo for AZD5148 and AZD5148 given by intravenous infusion, and the brief summary also says the study evaluates a single dose given by intramuscular or intravenous push during standard of care antibacterial therapy.[1]
The planned enrollment is 259 participants.[1] The source data does not list any additional trial sites, secondary outcomes, or subgroup details.[1]
