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Study on Optimizing Initial Dosing of Flucloxacillin and Drug Combination for Critically Ill Patients with Sepsis in the ICU

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of sepsis, a serious condition that occurs when the body's response to an infection causes injury to its own tissues and organs. The study will use a group of medications known as beta-lactam antibiotics, which are commonly used to treat bacterial infections. The specific medications being tested include Floxapen (flucloxacillin), Cefuroxim Hikma (cefuroxime), Ceftriaxon Fresenius Kabi (ceftriaxone sodium), Amoxicilline/Clavulaanzuur Sandoz (amoxicillin and clavulanic acid), Cefotaxim (cefotaxime), Piperacilline/Tazobactam Fresenius Kabi (piperacillin and tazobactam), Amoxicilline CF (amoxicillin), Ceftazidim Fresenius Kabi (ceftazidime pentahydrate), and Meropenem (meropenem trihydrate). These medications will be administered intravenously, meaning they will be given directly into a vein.

The purpose of the study is to determine if using a new dosing strategy for these antibiotics can improve the clinical outcomes of patients with sepsis who are in the Intensive Care Unit (ICU). Participants in the study will receive either the new dosing strategy or a standard treatment, which may include a placebo. The study will last for a maximum of three days, during which the effects of the treatment will be closely monitored.

Throughout the study, researchers will observe various health indicators, such as blood levels of the antibiotics and infection markers like C-reactive protein (CRP) and white blood cell count. The primary focus will be on the 28-day survival rate of the patients, but other factors like the length of hospital and ICU stays, as well as long-term survival up to 365 days, will also be evaluated. This research aims to provide valuable insights into optimizing antibiotic treatment for critically ill patients with sepsis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is admitted to the intensive care unit (ICU) with a primary infection and meets the criteria for septic shock. The patient is 18 years or older and begins receiving intravenous antibiotic therapy.

  2. Step 2

    Initial treatment

    The patient receives one of the following beta-lactam antibiotics intravenously: flucloxacillin, cefuroxime, ceftriaxone sodium, amoxicillin with clavulanic acid, cefotaxime, piperacillin with tazobactam, amoxicillin, ceftazidime pentahydrate, or meropenem. The specific dosage and frequency depend on the patient's condition and the chosen medication.

  3. Step 3

    Monitoring and adjustments

    Blood levels of the antibiotics are measured at 24, 48, and 72 hours after starting therapy to ensure optimal dosing. Infection parameters such as C-reactive protein (CRP), procalcitonin, and white blood cell count are monitored to assess the patient's response to treatment.

  4. Step 4

    Ongoing assessment

    The patient's progress is evaluated through various endpoints, including 28-day, 90-day, and 365-day mortality rates, as well as the length of stay in the hospital and ICU. The study also considers the number of adverse events, serious adverse events, and suspected unexpected serious adverse reactions.

  5. Step 5

    Post-study evaluation

    After the study, the costs in both study groups are calculated. The patient's quality of life is assessed using the EQ5D questionnaire at 3 and 12 months after admission. The change in the Sequential Organ Failure Assessment (SOFA) score from the start to the end of the study is also evaluated.

Who can join the trial?

5 criteria

  • Must be **18 years of age** or older.
  • Must be receiving **intravenous antibiotic therapy**. This means getting antibiotics through a vein, including a type called **beta-lactam antibiotics** given continuously.
  • Must have a **primary infection**. This means the main source of infection in the body.
  • Must be admitted to the **ICU**. The ICU is the Intensive Care Unit, a special part of the hospital for very sick patients.
  • Must meet the **Sepsis-3 criteria for septic shock**. This means having sepsis along with shock, which requires starting **vasopressors**. Vasopressors are medicines that help keep blood pressure at a safe level. The blood pressure should be a **mean arterial pressure** of 65 mm Hg or higher. Also, the **serum lactate level** should be more than 2.0 mmol/L after getting enough fluids. Serum lactate is a measure of lactic acid in the blood, which can be high in severe infections.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with sepsis. Sepsis is a serious condition where the body has a strong reaction to an infection, which can lead to tissue damage and organ failure.
  • Patients who are not in the ICU (Intensive Care Unit). The ICU is a special department in a hospital that provides intensive treatment and monitoring for very ill patients.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who belong to vulnerable populations, which means groups of people who might need special protection or care.
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Investigated drugs

Beta-Lactam Antibiotics are a group of antibiotics used to treat a wide range of bacterial infections. In this clinical trial, they are being studied to see if a new dosing strategy can improve the outcomes for patients with sepsis in the intensive care unit (ICU). These antibiotics work by interfering with the bacteria's cell wall, ultimately killing the bacteria and helping to clear the infection.

What is already known about the treatment

Beta-Lactam Antibiotics – These medications are typically administered intravenously, allowing for rapid delivery into the bloodstream, which is crucial for treating severe infections like sepsis. Currently, beta-lactam antibiotics are well-established in medical practice and literature as a primary treatment for bacterial infections, particularly in critically ill patients. They are mainly used to treat a wide range of bacterial infections, including sepsis, by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. Beta-lactam antibiotics belong to the pharmacological class of antibiotics known as beta-lactams, which include penicillins, cephalosporins, and carbapenems.

Investigated diseases

Sepsis – Sepsis is a severe medical condition that occurs when the body's response to an infection causes widespread inflammation. This inflammation can lead to tissue damage, organ failure, and potentially, if not managed, can progress to septic shock. It typically begins with an infection in the lungs, urinary tract, skin, or gastrointestinal tract. As the condition progresses, it can cause a drop in blood pressure, leading to poor blood flow to vital organs. Symptoms may include fever, increased heart rate, increased breathing rate, and confusion. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512950-13-00Estimated enrolment988 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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