AuthorisedTherapeutic use (Phase IV)Interventional

Clinical impact of pharmacokinetic monitoring of antibiotics in critically ill patients

This study is for very sick patients in intensive care units (ICU) who are receiving specific antibiotics like Daptomycin, Meropenem, Cefepime, Linezolid, or Piperacillin. Researchers are closely monitoring how these antibiotics act in patients' bodies to see if it helps improve their treatment. They are looking at various factors such as how long patients stay in the ICU and hospital, time on breathing machines, and recovery from fever. The study also tracks body markers of infection and overall health scores. This research is a 'Phase IV' study, meaning it's looking at how well existing treatments work in real-world settings to improve care for seriously ill patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Enrolment target

384

Start

10 Jul 2023

Critical Patients admitted to the ICU

What is this study about?

Imagine someone is very poorly and needs strong antibiotics to fight an infection in intensive care. This study is all about making sure those antibiotics work as well as possible for them. Doctors already know that antibiotics are crucial, but sometimes, how much medicine is in a person's body can change depending on how sick they are or how their own body handles the drug.

This research, called a 'Phase IV' study, isn't testing brand new medicines but is looking at commonly used antibiotics like Daptomycin, Meropenem, Cefepime, Linezolid, and Piperacillin. The main idea is to carefully measure the amount of antibiotic in patients' bodies and see if adjusting the dose based on these measurements helps them get better faster and spend less time in the hospital or on breathing support. This kind of careful tracking is known as 'pharmacokinetic monitoring'.

The study will follow many important health signs. These include how long patients stay in intensive care and hospital, how long they need a breathing machine, if they have a fever, and certain markers in their blood that show infection or inflammation. Researchers will also use special scoring systems to understand a patient's overall health and how well their organs are working. By gathering all this information, the study aims to find out if this personalised way of giving antibiotics really makes a difference to how critically ill patients recover.

Key takeaways

This study aims to improve antibiotic treatment for very ill patients.
It focuses on patients in intensive care units (ICU).
Doctors will closely monitor antibiotic levels in patients' bodies.
The goal is to see if this helps patients recover faster and better.
It's about making existing medicines work more effectively.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old. The study is specifically looking for patients who are very unwell and have been admitted to an intensive care unit (ICU).

There are no restrictions based on whether you are male or female; anyone meeting the age and critical illness criteria could be considered.

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 admitted to an intensive care unit (ICU)?
Are you being treated for a serious illness?
Are you receiving antibiotics like Daptomycin, Meropenem, Cefepime, Linezolid, or Piperacillin?

Answer every question to see your result.

What does participation involve?

If you or your loved one takes part in this study, you would already be receiving care in the intensive care unit for a serious illness. The study involves keeping a very close eye on the antibiotics you are given, such as Daptomycin, Meropenem, Cefepime, Linezolid, or Piperacillin. This will mean regular blood tests to check how much of the antibiotic is in your body and to monitor other general health markers like kidney and liver function.

The medical team will also be closely tracking your overall health, including how long you stay in the ICU, whether you need a breathing machine, your body temperature, and other signs of recovery. This careful tracking will happen throughout your treatment in the ICU and likely for a period after, potentially up to 30 days, to see how you are recovering. All these assessments are part of the detailed medical care you would already be receiving, but with specific focus for the study.

Potential risks and benefits

Participating in this study might offer the benefit of receiving even more carefully tailored antibiotic treatment, which could potentially improve your recovery from a serious infection. The main risks involve the additional blood tests needed to monitor antibiotic levels, although these are generally safe procedures. You have the full 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
Spain

Common questions

What is the main goal of this study?

The study wants to see if closely checking antibiotic levels in very sick patients helps them recover better and faster.

Who can join this study?

Adults (18+) who are seriously ill and in an intensive care unit (ICU) can take part.

What kind of treatments are being looked at?

The study is focusing on how well common antibiotics like Daptomycin, Meropenem, Cefepime, Linezolid, and Piperacillin work.

Will I have more tests if I join?

You might have extra blood tests to check the antibiotic levels in your body, alongside your usual medical checks.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your medical care.