AuthorisedTherapeutic confirmatory (Phase III)Interventional

BICCS - Beta-lactam Intermittent versus Continuous infusion and Combination antibiotic therapy in Sepsis

This study, called BICCS, is looking into the best way to give antibiotics to patients who have sepsis, a very serious type of infection. Doctors are comparing two main approaches: giving antibiotics continuously (like a steady drip) versus giving them in separate, regular doses. They are also comparing different combinations of antibiotics, including common ones like Ceftazidime and Meropenem, and others like Piperacillin and Amikacin. The main goal is to find out if one method is safer and more effective at reducing deaths within 30 days of treatment. This is a Phase 3 study, meaning it's a key step to confirm if these treatments work well for patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

600

Start

26 Nov 2024

antibiotic therapy in Sepsis

What is this study about?

Sepsis is a life-threatening illness caused by your body's overwhelming response to an infection. It can cause organ damage and can be very dangerous. When someone has sepsis, doctors need to act quickly to treat the infection with antibiotics. This study, called BICCS, is designed to help us understand the very best way to give these important antibiotics.

The researchers are comparing two main ways of giving antibiotics. One method is called 'continuous infusion,' where the antibiotic steadily enters the body over a longer period. The other is 'intermittent infusion,' which means the antibiotic is given in doses at specific times, like every few hours. They are also testing various types of antibiotics, both alone and in combination, to see which ones work best against the bacteria causing sepsis.

The main aim of this study is to see if one of these treatment approaches can lead to fewer deaths within 30 days for patients with sepsis. They will also be looking at other important things, like whether patients get better clinically, if they develop any new infections, and how well the antibiotics reach and fight the bacteria in the body. The goal is to improve how we treat sepsis and help more people recover.

Key takeaways

Tests different ways of giving antibiotics for sepsis.
Aims to reduce deaths within 30 days.
Looks at continuous vs. intermittent antibiotic delivery.
Compares various antibiotic types and combinations.
For adults aged 18 and over with sepsis.
Results could improve future sepsis treatment.

Who may be eligible?

This study is open to adult patients, meaning anyone 18 years old or older. Both men and women can take part.

To be considered, you would be a patient who has been diagnosed with sepsis and needs antibiotic treatment. The study doctors will carefully check your medical condition to make sure this study is right for you and that you meet all the specific requirements.

There might be certain health conditions or other medications you're taking that could prevent you from joining, as the researchers need to ensure the study is safe and effective for everyone involved.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with sepsis?
Are you currently receiving antibiotic treatment for your infection?
Do you have any other significant health conditions that might affect taking part?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you participate in this study, you will receive antibiotics as part of your sepsis treatment. The way these antibiotics are given (either continuously or in separate doses) and the specific types of antibiotics you receive will be decided by the study team. You will have regular checks by doctors and nurses, including examinations, blood tests, and other assessments to monitor your health and how you're responding to treatment. These assessments will help the researchers understand if the treatment is working and if you're experiencing any side effects. The main period of observation for the study is 30 days to check your recovery and overall health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving closely monitored and potentially optimised antibiotic treatment for your sepsis. You would also be contributing to medical knowledge that could help future patients with sepsis. As with any medication, antibiotics can have side effects, and the study team will closely monitor you for these. There's also the chance that the experimental treatment might not be more effective than standard care. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is sepsis?

Sepsis is a serious condition where your body has an extreme and life-threatening reaction to an infection. It can damage organs and needs urgent medical care.

What kind of treatments are being tested?

This study is looking at different ways to give antibiotics (continuously or in separate doses) and different combinations of antibiotics to treat sepsis.

Why is this study important?

It's important because it aims to find the best and most effective ways to treat sepsis, which could help save lives and improve recovery for many patients.

Who can join this study?

Adults aged 18 or over who have sepsis and meet specific health criteria determined by the study doctors can be considered for this study.

Will I know which treatment I am receiving?

Sometimes in studies like this, patients are randomly assigned to a treatment group. The study team will explain how this works if you are eligible.