A trial to learn how well AZD5148 works and how safe it is in people with a Clostridioides difficile infection

Researchers are looking for a better way to prevent an infection caused by a type of bacteria called Clostridioides difficile, also known as C. difficile. 

The trial drug AZD5148 is a type of drug called a monoclonal antibody.
Monoclonal antibodies are proteins that are created in a lab and work differently to antibiotics. The trial drug is designed to prevent CDI.

Researchers believe that AZD5148 could help prevent CDI from coming back when given with antibiotic treatment for CDI. In this trial, researchers want to learn how well AZD5148 works and how safe it is in people with CDI.

C. difficile is a type of bacteria that causes infections in the large intestine. It can cause frequent and severe diarrhoea, abdominal (stomach) pain and fever. C. difficile can affect people of any age, and it most commonly happens after taking antibiotics. Other factors may also increase the risk of an infection, including:

• Long stays in healthcare settings such as hospitals 

• Having a weakened immune system 

• Being over 65 years old 

C. difficile is usually treated with antibiotics that target the infection, but it may come back in around 1 in 5 people. This is known as a recurrent infection.

To join this trial, people must be at least 18 years old and have CDI. 

In this trial, some participants will receive the trial drug AZD5148, and some will receive a placebo. The placebo in this trial does not have any AZD5148 in it. Researchers use a placebo to help make sure any of the effects they see in the participants who take AZD5148 are actually caused by AZD5148. All participants will also receive antibiotic treatment for CDI. 

Participants will receive the trial treatment through an IV (a needle inserted into a vein) or through an injection in the thigh muscle.  

The treatment will be given only once at the start of the trial, and researchers will follow the participant’s progress for about 1 year. 

During the trial, the study team will also do the following: 

• Test the participants’ blood, urine, and stool 

• Perform physical exams 

• Check the participants’ vital signs 

• Test the participants’ heart function using an electrocardiogram (ECG)  

• Ask about the participants’ medications and any medical problems 

• Ask the participants to complete questionnaires about their symptoms