AuthorisedTherapeutic use (Phase IV)Interventional

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.

This study, called DALI-2, is investigating how well antibiotics work in critically ill patients who have serious infections. Doctors need to make sure that these powerful medicines reach the correct levels in the body to be most effective. If the level is too low, the infection might not clear, and if it's too high, it could cause side effects. The research involves checking the levels of various antibiotics in patients' blood. By doing this, scientists hope to understand if the current ways of giving antibiotics to very sick patients are working as well as they should. The goal is to improve how antibiotics are used so that patients get the best possible treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire De Nimes

Enrolment target

200

Start

17 Oct 2025

Serious infections in critically ill patients treated with antibiotics

What is this study about?

When someone is very poorly with a serious infection, they often need strong medicines called antibiotics. These antibiotics work best when they reach a certain level in the body. If there isn't enough medicine, it might not kill all the germs, and the infection could get worse. But if there's too much, it could cause unwanted side effects or harm.

This study, named DALI-2, is all about making sure that critically ill patients are getting the right amount of antibiotics. Doctors and researchers want to see if the way antibiotics are currently given to very sick patients helps the medicines reach the perfect level in their blood. They will be looking at many different types of antibiotics to understand this better.

The main aim is to check the amount of antibiotic in patients' blood and see if these levels are effective in fighting the infection, improving how quickly patients recover, and helping them get out of intensive care. By carefully studying this, doctors can learn how to give antibiotics more effectively in the future, helping patients recover faster and safer from serious infections.

Key takeaways

The study helps ensure antibiotics work best for very sick patients.
It checks antibiotic levels in the blood to find the ideal dose.
It aims to improve recovery from serious infections.
Participation involves routine blood tests and monitoring.
Anyone 18+ receiving certain antibiotics for serious infections may be eligible.

Who may be eligible?

This study is open to adults aged 18 years and older. There are no upper age limits, so older adults can also take part.

Both men and women can participate in this research. The study needs to include a wide range of patients to get a full picture of how antibiotics work in different people.

To be eligible, you would need to be a critically ill patient who is being treated with antibiotics for a serious infection. The medical team looking after you would determine if your specific situation fits the study's requirements.

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 a critically ill patient?
Are you currently receiving antibiotics for a serious infection?
Has your doctor discussed this study with you?

Answer every question to see your result.

What does participation involve?

If you are already a critically ill patient receiving antibiotics, taking part in this study would involve your medical team collecting extra blood samples. These samples would be used to measure the levels of antibiotics in your body. This is usually done as part of your normal care, so it wouldn't involve extra needles or discomfort beyond what you would already experience.

The study would also involve your doctors keeping a close eye on how you are responding to the antibiotics, how your infection is progressing, and any side effects you might experience. This information would be collected from your medical records and during your routine care. There are no extra visits or special appointments required for this study. Your participation would continue for a short period while you are receiving the specific antibiotic being studied, and your health would be monitored for up to 30 days after starting the antibiotic.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information found could help improve antibiotic treatment for future patients. The risks are very low, as it mainly involves taking extra blood samples during your routine care, which might cause minor discomfort or bruising like any blood test. You are completely free to decide if you want to take part or not, and you can 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.

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Unverified
France

Common questions

What is the main goal of this study?

The main goal is to find out if the antibiotics given to very ill patients reach the right levels in their bodies to fight serious infections effectively.

Who can join this study?

Adults aged 18 or over, both men and women, who are critically ill and receiving certain antibiotics for a serious infection can join.

Will taking part involve extra discomfort?

Participation mainly involves taking extra blood samples during your regular blood tests, so it shouldn't cause much extra discomfort.

Will I get a special medicine if I join?

No, you will receive the antibiotics your doctors have already decided are best for your treatment. This study simply monitors how well those medicines work in your body.

Can I change my mind about participating?

Yes, you can choose to stop participating at any time, and this will not affect the medical care you receive.