In short
Clinical trials are investigating HUMANISED IGG1 KAPPA (YTE) MONOCLONAL ANTIBODY AGAINST CLOSTRIDIOIDES DIFFICILE, TOXIN B in people with recurrence of Clostridioides difficile infection. The study aims to evaluate efficacy against recurrence, with a focus on patients receiving standard antibacterial treatment. This article summarizes the trial design, phase, target population, and main outcome being measured.
Key points
- Clinical trials are studying HUMANISED IGG1 KAPPA (YTE) MONOCLONAL ANTIBODY AGAINST CLOSTRIDIOIDES DIFFICILE, TOXIN B in people with recurrence of Clostridioides difficile infection. The trial is in Phase 2 and is authorised. It compares the study treatment with placebo during standard antibacterial treatment. The main goal is to reduce the first recurrence of infection through Day 91. The study is interventional and plans to enroll 259 people.
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. The study is designed to see whether the treatment can lower the chance of the infection coming back after standard treatment.
Who can participate
The source data says the trial is for people with recurrence of Clostridioides difficile infection. It does not give more detailed inclusion rules such as age limits, lab values, or past treatment history.
What is being measured
The main outcome is the first occurrence of recurrent C. difficile infection. This means the researchers are checking whether a new episode happens after treatment, and they follow this through Day 91.
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. The trial status is Authorised.
Study design and treatment groups
The trial is interventional, meaning researchers assign the study treatment to participants. 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.
The planned enrollment is 259 participants. The source data does not list any additional trial sites, secondary outcomes, or subgroup details.