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AuthorisedTherapeutic exploratory (Phase II)Interventional

Early optimization of ceftazidine dosing regimen in critical care : FORTOPTIM_1

This study is looking at the best way to give an antibiotic called ceftazidime to adults who are very ill with sepsis. Sepsis is a life-threatening reaction to an infection. The main aim is to find the right amount of the antibiotic to give so that it fights the infection effectively, but without being too much and causing harm. Doctors will measure the amount of ceftazidime in the blood at different times after it's been given. This helps them understand how the body uses the medicine. They also want to see if this improved dosing helps patients get better and avoids side effects, particularly those affecting the brain and kidneys. Finding the best dose could make a real difference for critically ill patients.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Centre Hospitalier Universitaire De Saint Etienne
Enrolment target
128
Start
24 Jul 2025

What is this study about?

This study is focusing on people who are very unwell with a serious condition called sepsis. Sepsis happens when your body has an overwhelming response to an infection, which can be life-threatening and affect many organs. When someone has sepsis, doctors often use strong antibiotics to fight the infection. One such antibiotic is called ceftazidime. The main goal of this study is to work out the very best way to give ceftazidime to these seriously ill patients. It's like finding the 'sweet spot' for the medicine – making sure there's enough of it in your body to kill the infection effectively, but not so much that it causes unwanted side effects. Researchers will be carefully measuring the amount of ceftazidime in patients' blood at specific times after they receive their first dose. This helps them understand how the body uses and processes the medicine. By making sure the dose is just right, the hope is to improve how well patients recover from sepsis and to reduce the risk of side effects. Side effects can sometimes affect important organs like the brain or kidneys. The study will also look at how patients' overall health changes during their time in hospital, using a special scoring system to check how well different body parts are working. Ultimately, the findings from this study could help doctors give ceftazidime more effectively and safely to future patients with sepsis, leading to better outcomes.

Key takeaways

  • This study is for adults with sepsis in critical care.
  • It aims to find the best dose of the antibiotic ceftazidime.
  • Measuring drug levels in the blood is key to finding the right dose.
  • The goal is better and safer treatment for sepsis.
  • Your general health and organ function will be closely monitored.

Who may be eligible?

To join this study, people must be 18 years old or older. The study is open to both men and women.

The specific reasons why someone might not be able to join are not fully listed here, but usually, patients in these types of studies will have been diagnosed with sepsis and be receiving care in a critical care unit.

Your doctor will be able to tell you if you meet all the necessary requirements to take part.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with sepsis?
  3. Are you currently receiving critical care in hospital?
  4. Are you willing for doctors to take extra blood samples to monitor drug levels?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the antibiotic ceftazidime as part of your treatment for sepsis. Doctors will carefully monitor the amount of this medicine in your blood. This usually involves taking small blood samples at specific times, for example, 3 and 24 hours after your first dose. Your doctors will also regularly check your overall health using a system called the SOFA score, which assesses how well your organs are working. This check will happen when you first join the study and again about a week later. They will also look out for any new symptoms, especially those that might affect your brain, and monitor your kidney function through blood and urine tests. The study will follow your progress up to 28 days to see how you are recovering. All these assessments are part of your standard care in critical care, but in the study, they will be used to understand the effects of the specific ceftazidime dosing. The total duration of your participation in the study follow-up is up to 28 days.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving an optimized dose of ceftazidime, which could potentially lead to more effective treatment for your sepsis and a lower risk of side effects. However, as with any medical treatment, there are potential risks. The study involves extra blood tests to measure drug levels, which could cause minor discomfort or bruising. Doctors will also carefully monitor for any side effects, including those affecting the brain or kidneys, to ensure your safety. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time 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.
  • Unverified
    France

Common questions

What is sepsis?

Sepsis is a serious and life-threatening condition when your body's immune system overreacts to an infection, leading to widespread inflammation and organ damage.

What is ceftazidime?

Ceftazidime is an antibiotic, a type of medicine used to treat bacterial infections. It's often used for serious infections in hospital settings.

Why is this study important?

This study aims to find the best amount (dose) of ceftazidime to give to patients with sepsis, so it works effectively to fight the infection while also being as safe as possible.

Will I get extra medicine?

You will receive ceftazidime as part of your treatment. The study is about finding the best way to give that medicine, not about giving you an additional, untested drug.

What does 'critical care' mean?

Critical care, also known as intensive care, is for people who are extremely ill or have life-threatening injuries, where they need close monitoring and often support for their vital organs.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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