Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Pharmacokinetics study of Cefazolin in haemodialysis (CEFAZODIAL)

This research, called CEFAZODIAL, is studying an antibiotic called Cefazolin. We're focusing on patients who are on regular kidney dialysis and have an infection. Cefazolin is a common antibiotic, and we want to understand how long it stays in the body at a level that can fight off bacteria. By understanding this, doctors can make sure patients receive the right amount of medicine at the right time. We'll also be checking if the treatment works well to clear up infections and if there are any side effects. This helps us ensure the medicine is both effective and safe for this group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Enrolment target

Start

05 Oct 2023

Chronic haemodialysis patients suffering from infection.

What is this study about?

This study, named CEFAZODIAL, is looking into how a well-known antibiotic called Cefazolin works in people who are on regular kidney dialysis and have an infection. When kidneys don't work properly, medicines can stay in the body for longer or clear out differently compared to people with healthy kidneys. This means that doctors need to understand how antibiotics behave in dialysis patients to give them the most effective dose.

The main goal of this research is to measure how long Cefazolin stays at a good level in the patient's blood – a level that is strong enough to kill the infection. We'll also be watching closely to see if the treatment successfully clears up the infection within a week and again after six weeks. It's really important to make sure the infection goes away and doesn't come back. We will also be looking out for any side effects from the medication.

Basically, this study aims to find the best way to give Cefazolin to patients on dialysis so that it's as effective and safe as possible in treating their infections. This is important information that helps doctors make better decisions about treatment for patients like you.

Key takeaways

Study looks at Cefazolin in dialysis patients with infections.
Aims to find the best way to dose the antibiotic.
Monitors how long the medicine stays effective in the blood.
Checks if infections clear up and don’t come back.
Looks for any side effects of the treatment.

Who may be eligible?

To take part in this study, you must be an adult, aged 18 years or older. There is no upper age limit, and both men and women can be considered for the study.

The study is specifically for people who are currently receiving regular haemodialysis, which is a type of kidney dialysis. You also need to have an infection that requires treatment with the antibiotic Cefazolin.

Your doctor will check other specific medical details to make sure this study is right for you and that taking part would be safe and beneficial for your health. They will discuss all the requirements with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving regular kidney dialysis?
Do you have an active infection that needs antibiotic treatment?
Has your doctor told you Cefazolin is a suitable treatment for your infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive Cefazolin as part of your treatment for infection. The study will involve extra blood tests to measure the levels of Cefazolin in your body at different times. This helps us understand how your body handles the medicine.

Your doctors and the study team will closely monitor your infection's progress and check for any side effects. This will happen at specific times: one week after starting the medicine and again six weeks after your last dose. The team will also be in regular contact with you to see how you're feeling. The exact number of visits or tests will be explained by the study team, but it primarily involves close monitoring during your antibiotic treatment and follow-up.

Potential risks and benefits

Taking part in this study might offer the benefit of having your antibiotic treatment carefully monitored by specialists, potentially leading to a better understanding of how the medicine works in your body. However, as with any medicine, there is a chance of side effects from Cefazolin, and your care team will explain these to you. There is also the added inconvenience of extra blood tests. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Cefazolin?

Cefazolin is a common antibiotic used to treat various bacterial infections.

Why is this study only for people on dialysis?

Dialysis changes how medicines are processed in the body, so we need to find the best way to give Cefazolin specifically to these patients.

Will I get special treatment if I join?

You will receive the standard Cefazolin treatment for your infection, but your body's response to the medicine will be monitored more closely as part of the study.