AuthorisedPhase III and phase IV (Integrated)Interventional

BETARGET : Randomized trial of individualizing BETA-lactam taRGET combining therapeutic drug monitoring, minimal inhibitory concentration and model-based dose adjustment, in Intensive Care Units patients with gram negative bacilli infection

Sepsis is a life-threatening reaction to an infection that requires urgent care in an intensive care unit (ICU). Patients often receive standard doses of antibiotics, but their bodies process medicines very differently when they are severely unwell. This clinical trial is testing a new, personalised approach to antibiotic treatment. Doctors will measure the exact amount of antibiotic in a patient's blood and check how strong the infection is. They will then use special computer programmes to work out the ideal dose for that individual. Researchers want to find out if this tailored method helps patients recover more quickly, cuts down the need for life support machines, and gets people home from the hospital sooner compared to standard dosing. The trial involves common antibiotics and will monitor patients closely over 28 days.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Universitaire De Rennes

Enrolment target

672

Start

06 Aug 2026

sepsis

What is this study about?

When someone becomes critically ill with a severe infection, their body can develop sepsis. Sepsis is a medical emergency that can quickly cause organs like the kidneys, heart, and lungs to struggle. Patients with sepsis are cared for in an intensive care unit (ICU), where they often need breathing machines, kidney support, and strong antibiotics given directly into a vein.

Usually, doctors give antibiotics using fixed, standard doses. However, when a person is fighting a severe illness, their blood flow, kidney function, and fluid levels change rapidly from day to day. This means that a standard dose might end up being too low to kill the bacteria quickly, or higher than needed. Getting the dose just right can be tricky, especially in the first few critical days of care.

This trial is testing whether a personalised dosing system works better. By taking regular blood tests to check medicine levels and testing the specific bacteria causing the infection, doctors use computer models to adjust the antibiotic dose to the patient's exact needs. The goal is to see if this tailored care helps people recover faster, reduces time spent on life support, and helps patients leave the ICU sooner.

Key takeaways

The trial tests whether personalised antibiotic doses help ICU patients recover from severe infections like sepsis faster.
Special computer models and blood tests are used to calculate the exact dose for each patient.
Participation happens entirely within the intensive care unit, with no extra travel needed.
Patients are monitored closely over a 28-day period to measure recovery and time spent off life support.
Taking part is voluntary, and standard high-quality care will continue regardless of participation.

Who may be eligible?

This study is designed for adults aged 18 and older who are currently being treated in an intensive care unit for a severe bacterial infection or sepsis.

To be considered, patients must be receiving, or about to receive, standard beta-lactam antibiotics. These are common antibiotics such as amoxicillin, piperacillin, or meropenem. Because patients in the ICU are often very unwell and may be asleep on breathing machines, doctors will usually speak to family members or legal representatives about joining the study.

People who are under 18 or who have severe known allergies to these specific antibiotics will not be able to take part. The intensive care medical team will review each patient's condition to make sure the trial is safe and appropriate for them.

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.

The patient is aged 18 or older.
The patient is currently being treated in an intensive care unit (ICU).
The patient has a severe bacterial infection or sepsis.
The patient is being treated with standard beta-lactam antibiotics.
The patient does not have a severe allergy to the study antibiotics.

Answer every question to see your result.

What does participation involve?

Because this trial takes place while the person is already staying in the intensive care unit, there are no extra hospital visits needed. All assessments happen at the bedside as part of the patient's daily critical care.

If someone takes part, they will receive their antibiotics either through the standard dosing method or through the new personalised dosing method. The study team will take small blood samples to check the level of antibiotic in the bloodstream and test samples (such as phlegm or urine) to see how the bacteria are responding. Doctors will track organ recovery, the need for breathing machines or kidney support, and watch for any side effects.

The main study period lasts for 28 days from the day the patient joins. If the patient is well enough to leave the ICU or hospital before day 28, the doctors will simply check in on their health records up to that point.

Potential risks and benefits

A potential benefit of joining this study is receiving an antibiotic dose precisely matched to your body's needs, which might help clear the infection faster and speed up recovery. However, this cannot be guaranteed. The risks include typical side effects of antibiotics, such as stomach upset, skin rashes, or changes in kidney function, though these medicines are already standard treatments. The extra blood tests are taken from lines already placed for intensive care, so they rarely cause extra discomfort. Taking part is completely voluntary. Patients or their families can choose to stop participating at any time without it affecting the quality of standard NHS 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 are beta-lactam antibiotics?

They are a very common family of antibiotics, including penicillin, amoxicillin, and meropenem, used widely across the NHS to treat serious bacterial infections.

Will taking part delay my loved one's treatment?

No. Antibiotics are started immediately in critical care. Joining the study only changes how doctors calculate and adjust the doses.

Does this study involve extra needle pricks?

Usually not. ICU patients almost always have small plastic tubes (catheters or lines) already in their veins, which are used to take blood samples painlessly.

Who decides if someone can join if they are unconscious?

If a patient is too unwell to give consent, doctors consult their next of kin or an independent doctor to act in their best interests, following strict UK legal guidelines.

What happens after the patient leaves the intensive care unit?

Once a patient leaves the ICU, the study team simply reviews their medical notes until day 28 to confirm they are continuing to recover well.