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Study on the Effects of Antibiotic Monitoring in ICU Patients Using Meropenem and Drug Combination

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What is this trial about?

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

This clinical trial focuses on patients who are critically ill and admitted to the Intensive Care Unit (ICU). The study examines the use of several antibiotics, including Meropenem, Cefepime, Piperacillin, Linezolid, and Daptomycin. These antibiotics are administered to help fight infections in patients who are severely unwell. The purpose of the study is to understand how monitoring the levels of these antibiotics in the blood can impact the treatment outcomes for these patients.

During the study, patients will receive one of the antibiotics mentioned above. The treatment will be given through a vein, which is known as intravenous administration. The study will observe how the antibiotics are processed in the body and how this affects the patient's recovery. The study will also compare the outcomes of patients who receive regular monitoring of antibiotic levels with those who do not. This will help determine if monitoring can improve the effectiveness of the treatment.

The study will track various health indicators, such as the number of days patients spend in the ICU, the duration of hospital stays, and the need for mechanical ventilation. It will also monitor the presence of fever and certain biomarkers, which are substances in the body that can indicate how well the treatment is working. The study aims to provide valuable insights into the best ways to use antibiotics in critically ill patients to improve their chances of recovery.

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, you will be assigned to either the intervention group or the control group. This assignment is based on when you start your treatment with the antibiotics being studied.

    If you are in the intervention group, your treatment will begin within 48 hours before a scheduled blood test to measure the concentration of the antibiotic in your blood. If you are in the control group, your treatment will start after the intervention group's blood test, and the number of patients in both groups will be balanced weekly.

  2. Step 2

    Treatment administration

    You will receive one or more of the following antibiotics through an intravenous (IV) line: daptomycin, meropenem, cefepime, linezolid, or piperacillin. The specific antibiotic, dosage, and frequency will be determined by your medical team based on your condition.

    The duration of the antibiotic treatment will depend on your response to the medication and your overall health status.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular checks of your vital signs, blood tests to measure antibiotic levels, and assessments of your overall health condition.

    Specific health indicators such as days in the intensive care unit (ICU), days on mechanical ventilation, and other relevant health markers will be recorded.

  4. Step 4

    Follow-up evaluations

    Your progress will be evaluated at various points during the study, including on days 1, 3, 7, and at the end of your treatment. These evaluations will include blood tests and other necessary health assessments.

    The study will also track any changes in your health status, such as the presence of fever, changes in specific blood markers, and any other relevant clinical data.

  5. Step 5

    Completion of the study

    At the end of the study, a final assessment will be conducted to evaluate your overall health and the effectiveness of the antibiotic treatment.

    The study aims to understand the impact of monitoring antibiotic levels in critically ill patients, and your participation will contribute valuable information to this research.

Who can join the trial?

5 criteria

  • Must be at least 18 years old.
  • Must be admitted to the Intensive Care Unit (ICU).
  • Must start treatment with one of the following antibiotics: meropenem, cefepime, piperacillin/tazobactam, linezolid, or daptomycin.
  • For the intervention group: Treatment must begin within the 48 hours before the scheduled time for measuring antibiotic levels in the blood.
  • For the control group: Treatment must start after the scheduled time for measuring antibiotic levels in the blood, and continue until the same number of patients as in the intervention group is reached that week.

Who cannot join the trial?

4 criteria

  • Patients who are not in a critical condition and not admitted to the ICU (Intensive Care Unit) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so those outside these groups are excluded.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.
  • Patients who are not receiving any of the specific antibiotics being studied, such as meropenem, cefepime, piperacillin/tazobactam, linezolid, and daptomycin, cannot participate.
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Investigated drugs

  • Meropenem

    is an antibiotic used to treat serious infections caused by bacteria. It works by killing the bacteria or stopping their growth. In this trial, it is being monitored to see how well it works in patients who are very sick.

  • Cefepime

    is another antibiotic that fights bacterial infections. It is often used for severe infections and is being studied in this trial to understand its effectiveness in critically ill patients.

  • Piperacillin/Tazobactam

    is a combination of two medications. Piperacillin is an antibiotic that kills bacteria, and Tazobactam helps prevent bacteria from becoming resistant to Piperacillin. This combination is being monitored in the trial to see how it performs in very sick patients.

  • Linezolid

    is an antibiotic used to treat certain serious bacterial infections. It works by stopping the growth of bacteria. The trial is looking at how well Linezolid works in patients who are critically ill.

  • Daptomycin

    is an antibiotic that treats serious infections caused by bacteria. It works by killing the bacteria. In this study, Daptomycin is being monitored to assess its effectiveness in very sick patients.

What is already known about the treatment

  • Meropenem

    Meropenem is administered as an injection directly into a vein, typically in a hospital setting. It is currently used in medical practice to treat severe infections in critically ill patients, especially those in intensive care units (ICUs). The main therapeutic use of meropenem is to combat serious bacterial infections. At the molecular level, it works by interfering with the bacteria's ability to build their cell walls, which ultimately leads to the bacteria's death. It belongs to a class of drugs known as carbapenem antibiotics.

  • Cefepime

    Cefepime is given as an intravenous injection, usually in a hospital environment. It is widely recognized in medical literature for treating severe bacterial infections in critically ill patients, particularly those in ICUs. Its primary therapeutic indication is to fight serious infections caused by bacteria. Cefepime acts by disrupting the bacteria's cell wall synthesis, leading to bacterial cell death. It is classified as a fourth-generation cephalosporin antibiotic.

  • Piperacillin/Tazobactam

    Piperacillin/Tazobactam is administered through an injection into a vein, often in a hospital setting. It is currently used in medical practice to treat severe infections in critically ill patients, especially those in ICUs. The main therapeutic indication is to treat serious bacterial infections. This combination works by piperacillin inhibiting bacterial cell wall synthesis and tazobactam preventing bacterial resistance to piperacillin. It is classified as a penicillin antibiotic combined with a beta-lactamase inhibitor.

  • Linezolid

    Linezolid is typically administered orally or through an intravenous injection, depending on the patient's condition. It is recognized in medical literature for treating severe infections in critically ill patients, particularly those in ICUs. The main therapeutic use of linezolid is to treat serious bacterial infections, including those resistant to other antibiotics. It works by inhibiting bacterial protein synthesis, which is essential for bacterial growth and reproduction. Linezolid is classified as an oxazolidinone antibiotic.

  • Daptomycin

    Daptomycin is administered as an injection into a vein, usually in a hospital setting. It is currently used in medical practice to treat severe bacterial infections in critically ill patients, especially those in ICUs. The main therapeutic indication is to combat serious infections caused by certain types of bacteria. Daptomycin works by disrupting the bacterial cell membrane, leading to cell death. It is classified as a lipopeptide antibiotic.

Investigated diseases

Critical Illness – Critical illness refers to a state where a patient experiences life-threatening health conditions that require intensive medical care. It often involves multiple organ dysfunctions or failures, necessitating admission to an Intensive Care Unit (ICU). Patients may require mechanical ventilation to support breathing and vasoactive drugs to maintain blood pressure. The condition can lead to significant physiological stress, affecting the body's ability to maintain normal function. Monitoring of vital signs, organ function, and biomarkers like procalcitonin and C-reactive protein is crucial. The progression of critical illness can vary widely depending on the underlying causes and the patient's response to treatment.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504480-17-00Protocol codeIIBSP-TDM-2023-28Estimated enrolment384 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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