Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Individualized beta‑lactam dosing with piperacillin (drug combination) for ICU patients with sepsis caused by gram‑negative bacteria

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with sepsis in the intensive care unit often receive antibiotics from the beta-lactam class, such as piperacillin, tazobactam, amoxicillin, cefotaxime, cefepime, ceftazidime, avibactam and meropenem. Sepsis is a serious condition where the body’s response to infection can damage its own organs, and prompt, effective antibiotic treatment is crucial.

The study aims to determine whether an individualized approach that combines therapeutic drug monitoring, minimal inhibitory concentration and model-based dose adjustment can improve outcomes for these patients. Therapeutic drug monitoring means measuring the amount of antibiotic in the blood, minimal inhibitory concentration is the lowest drug level that stops bacterial growth, and model-based dose adjustment uses computer calculations to set the right dose.

Participants will be randomly assigned to receive the standard antibiotic regimen or the individualized regimen. In the individualized group, blood samples are taken shortly after the infusion to check drug levels, and doses may be modified based on the results. Patients are followed for up to 28 days to record time spent in the intensive care unit, need for breathing support or kidney treatment, and survival, without any additional procedures beyond routine care.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study you give informed consent and provide basic health information.

    A blood sample is taken to measure the level of the antibiotic that will be used (therapeutic drug monitoring) and to determine the minimal inhibitory concentration (the lowest amount of drug that stops the bacteria).

  2. Step 2

    Start of antibiotic infusion

    You receive an intravenous infusion of a beta‑lactam antibiotic selected for the study.

    Possible drugs and their usual doses are:

    piperacillin 12 g, tazobactam 1.5 g per litre, amoxicillin 12 g, cefotaxime 12 g, cefepime 6 g, ceftazidime 6 g, meropenem 6 g, and avibactam 1.5 g.

    The infusion is given once a day (or as a continuous infusion according to the hospital protocol) for up to 7 days, or until you leave the intensive care unit, whichever comes first.

  3. Step 3

    Daily blood sampling for drug level monitoring

    Each day while you are receiving the antibiotic, a small amount of blood is drawn to check the drug concentration in your bloodstream.

    These results are used to keep the drug level within the range that is effective against the infection.

  4. Step 4

    Dose adjustment based on monitoring

    If the daily blood test shows that the drug level is too low or too high, the medical team may change the amount of drug you receive.

    Dose changes can occur during the first 7 days of treatment to ensure optimal effectiveness and safety.

  5. Step 5

    Daily clinical assessments

    Health professionals evaluate your condition each day, recording scores that reflect organ function (SOFA score) and checking for signs of brain dysfunction (encephalopathy) using a standard questionnaire.

  6. Step 6

    Microbiological test on day 3

    On the third day of antibiotic therapy a sample from your airway (tracheal aspiration) is taken.

    The laboratory checks whether the bacteria that caused the infection are no longer present.

  7. Step 7

    Weekly screening for resistant bacteria

    Once a week, additional samples are collected to look for bacteria that have become resistant to the antibiotics.

    This screening continues until day 28 or until you leave the intensive care unit.

  8. Step 8

    Clinical cure assessment at day 14

    Around the fourteenth day of your stay, clinicians determine whether you have achieved a clinical cure, meaning the infection signs have resolved.

    If you are ready for discharge from the intensive care unit earlier, the assessment may be done sooner.

  9. Step 9

    Final follow‑up at day 28

    On the twenty‑eighth day, the study records several outcomes, including the number of ICU free days (days you were alive and not in the intensive care unit), overall survival, and whether any additional antibiotics were needed.

    The total number of days you received any antibiotic during the 28‑day period is also documented.

Who can join the trial?

6 criteria

  • Age 18 or older – you must be an adult.
  • Being cared for in the Intensive Care Unit (ICU), which is a special hospital area for very sick patients.
  • Having sepsis, which means your body is having a severe reaction to an infection.
  • Having a lab test that shows infection with Enterobacterales (a common group of bacteria) or non‑fermenting Gram‑negative bacilli (a type of bacteria that does not break down sugars in lab tests).
  • Currently receiving a beta‑lactam antibiotic (a family of antibiotics) such as cefotaxime, ceftazidime, cefepime, piperacillin, piperacillin‑tazobactam, meropenem, amoxicillin, or ceftazidime‑avibactam.
  • Providing informed consent yourself, or having a relative or legal representative give consent, or using the study’s emergency consent procedure.

Who cannot join the trial?

7 criteria

  • Having an allergy to beta-lactams (a common type of antibiotic) prevents participation.
  • Having a urinary infection (an infection of the bladder or kidneys) excludes you.
  • Having a plurimicrobial infection (an infection caused by more than one kind of germ) excludes you.
  • Having a “complex” infection such as a central nervous system infection (infection of the brain or spinal cord) or a bone or joint infection excludes you.
  • Being a protected person, which includes adults under legal guardianship or supervision, people who are imprisoned, pregnant women, women who are breastfeeding, or children, excludes you.
  • If doctors cannot measure the MIC (the lowest amount of antibiotic needed to stop bacterial growth) of the bacteria causing the infection, you cannot join.
  • Lacking coverage by a social security or health‑insurance scheme excludes you.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Piperacillin

    is a beta‑lactam antibiotic that kills many types of bacteria. In the trial it is given by infusion to help treat serious infections caused by gram‑negative bacteria.

  • Tazobactam

    is a medicine that blocks enzymes some bacteria use to resist antibiotics. It is used together with piperacillin so the antibiotic can work better against resistant germs.

  • Amoxicillin

    is a penicillin‑type antibiotic that fights a wide range of bacterial infections. In the study it is given by infusion to treat patients with gram‑negative infections.

  • Cefotaxime

    belongs to the cephalosporin class of antibiotics. It has a broad spectrum of activity and is given by infusion to help clear serious gram‑negative bacterial infections.

  • Cefepime Dihydrochloride Monohydrate

    is a fourth‑generation cephalosporin antibiotic. It is strong against many gram‑negative bacteria, including those that are harder to treat, and is administered by infusion.

  • Ceftazidime

    is a cephalosporin antibiotic that works especially well against Pseudomonas and other gram‑negative germs. It is given by infusion as part of the treatment regimen.

What is already known about the treatment

  • Piperacillin

    This drug is given by intravenous infusion, where the medication is slowly dripped into a vein. It is an approved and widely used antibiotic for serious bacterial infections, especially in intensive care units. It works by stopping bacteria from building their cell walls, which leads to bacterial death. It belongs to the penicillin class of beta‑lactam antibiotics.

  • Tazobactam

    Tazobactam is administered together with other antibiotics through an intravenous infusion. It is a licensed beta‑lactamase inhibitor that is commonly combined with penicillins to treat resistant infections. It blocks enzymes that some bacteria use to destroy antibiotics, allowing the partner drug to work better. It is classified as a beta‑lactamase inhibitor.

  • Amoxicillin

    Amoxicillin is given by intravenous infusion in hospital settings for severe infections. It is a well‑established penicillin‑type antibiotic used for a wide range of bacterial infections, including sepsis. It interferes with the construction of the bacterial cell wall, causing the bacteria to burst. It is part of the penicillin subclass of beta‑lactam antibiotics.

  • Cefotaxime

    Cefotaxime is delivered by intravenous infusion and is approved for treating serious infections in the hospital. It is commonly used for infections caused by gram‑negative bacteria such as those seen in sepsis. It works by preventing bacteria from forming a strong cell wall, leading to their death. It is classified as a third‑generation cephalosporin.

  • Cefepime

    Cefepime is given by intravenous infusion for serious bacterial infections, especially in intensive care patients. It is an approved broad‑spectrum antibiotic used for gram‑negative and some gram‑positive infections. It stops bacteria from building their cell wall, which kills the bacteria. It belongs to the fourth‑generation cephalosporin class.

  • Ceftazidime

    Ceftazidime is administered through an intravenous infusion for severe infections, particularly those caused by resistant gram‑negative bacteria. It is a recognized third‑generation cephalosporin used in hospitals worldwide. It inhibits the formation of the bacterial cell wall, leading to bacterial death. It is classified as a third‑generation cephalosporin.

Investigated diseases

Sepsis - Sepsis is a systemic response to infection that triggers widespread inflammation. The inflammatory response can cause blood pressure changes and impair the function of vital organs such as the lungs, kidneys, and liver. As the condition advances, organ dysfunction may become more pronounced, leading to the need for supportive care. Ongoing inflammation can result in further tissue damage and worsening of organ performance. Monitoring of clinical signs helps to track the evolution of the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522819-42-01Protocol code35RC23_8883_BETARGETEstimated enrolment672 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.