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Study Comparing Different Antibiotic Treatments for ICU Patients with Hospital-Acquired Sepsis: Focus on Cefepime and Drug Combination

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 has an extreme response to an infection. The study will explore different ways of administering antibiotics to patients with sepsis acquired in the hospital. The antibiotics being studied include Avibactam, Ceftazidime, Tazobactam, Ceftolozane, Piperacillin, Cefepime, Amikacin, Meropenem, and Linezolid. Some of these medications are used in combination, such as Ceftazidime and Avibactam or Piperacillin and Tazobactam, to enhance their effectiveness against infections.

The purpose of the study is to compare the effectiveness of two different methods of administering these antibiotics: intermittent infusion and continuous infusion. This means that the study will look at whether giving the antibiotics in separate doses at intervals or continuously over time is more effective in reducing the 30-day mortality rate of patients with sepsis in the intensive care unit (ICU). The study will also involve a comparison with a placebo group to better understand the impact of the antibiotics.

Participants in the study will receive one of the antibiotic treatments for a period of up to seven days. The study will monitor the patients' health and recovery over a 30-day period to assess the outcomes. The goal is to determine which method of antibiotic delivery is more beneficial for patients with sepsis, potentially leading to improved treatment strategies in the future.

The research process

The trial runs in 6 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, participation begins with an initial assessment to confirm eligibility. This includes verifying the diagnosis of hospital-acquired sepsis and ensuring the presence of specific risk factors for resistant bacteria.

  2. Step 2

    Treatment initiation

    Treatment involves the administration of antibiotics. The specific antibiotics used include avibactam, ceftazidime, tazobactam, ceftolozane, piperacillin, cefepime, amikacin, and meropenem. These are administered through injection or infusion, depending on the specific medication and treatment plan.

  3. Step 3

    Treatment administration

    The antibiotics are given either intermittently or continuously, depending on the assigned group. The mode of administration is a key aspect of the study, comparing the effects of different delivery methods on patient outcomes.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment, regular monitoring is conducted to assess the effectiveness of the antibiotics and to check for any side effects. This includes measuring drug concentrations and evaluating the patient's response to treatment.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is the mortality rate at 30 days. Secondary outcomes include clinical failure, infection rates, and organ function. These outcomes help determine the effectiveness of the treatment methods.

  6. Step 6

    Completion of study participation

    Participation in the study concludes after the final assessments are completed. This includes a review of the patient's health status and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must be an adult (18 years or older).
  • Must have hospital-acquired sepsis, which means the infection was acquired in the hospital. This is defined as being hospitalized for more than 48 hours or discharged less than 48 hours ago, and sepsis diagnosed within the last 24 hours.
  • Must have one of the following risk factors for certain types of bacteria that are hard to treat with antibiotics:
    • Used intravenous antibiotics within 7 days before sepsis started, except for certain antibiotics that only work against specific bacteria.
    • Stayed in the hospital for 15 days or more within 3 months before sepsis started.
    • Used a breathing machine for 5 days or more within 3 months before sepsis started.
    • Have medical devices like dialysis lines, catheters, or feeding tubes.
    • Known to have or carry certain hard-to-treat bacteria within 3 months before sepsis started.
    • Used specific antibiotics like amoxicillin-clavulanic acid, C2G, C3G, or fluoroquinolones within 3 months before sepsis started.
    • Traveled to areas with a higher risk of these bacteria, such as the Indian subcontinent, South-East Asia, the Middle East, North Africa, or the Mediterranean Basin, within 3 months before sepsis started.
    • Have a problem with the urinary tract if the infection is in the urinary tract.
    • Must have had appropriate tests done to identify the bacteria before starting treatment.
    • Must be expected to stay in the Intensive Care Unit (ICU) for more than 3 days.

Who cannot join the trial?

4 criteria

  • Patients who are not in the Intensive Care Unit (ICU) with hospital-acquired sepsis cannot participate.
  • Patients who are not receiving antibiotic treatment for sepsis are excluded.
  • Patients who are not within the specified age range for the study cannot join. The study includes certain age groups only.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

  • Beta-lactam Antibiotic

    is a type of antibiotic used to treat bacterial infections. In this trial, it is being studied to see if different ways of giving the medication can affect the survival of patients with sepsis in the ICU. The study is comparing intermittent infusion (giving the medication at intervals) versus continuous infusion (giving the medication continuously) to see which method is more effective in reducing mortality.

  • Combination Antibiotic Therapy

    involves using more than one antibiotic at the same time to treat infections. This approach is being tested in the trial to determine if using a combination of antibiotics can improve outcomes for patients with sepsis compared to using a single antibiotic. The goal is to find the best treatment strategy to help patients recover from severe infections.

What is already known about the treatment

Beta-lactam Antibiotics – These medications are typically administered intravenously, either through intermittent or continuous infusion, especially in critical care settings like the ICU. They are currently well-established in medical practice and literature, particularly for treating severe infections such as sepsis. The main therapeutic indication for beta-lactam antibiotics in this context is to combat bacterial infections that lead to sepsis. At the molecular level, they work by inhibiting the synthesis of bacterial cell walls, which ultimately leads to the destruction of the bacteria. Beta-lactam antibiotics are classified pharmacologically as antibacterial agents, specifically targeting a broad range of bacteria.

Investigated diseases

Sepsis – Sepsis is a severe and potentially life-threatening condition that arises when the body's response to infection causes injury to its own tissues and organs. It typically begins with an infection that can be located anywhere in the body, such as the lungs, urinary tract, skin, or gastrointestinal tract. As the infection progresses, the immune system releases chemicals into the bloodstream to fight the infection, which can trigger widespread inflammation. This inflammation can lead to a cascade of changes that damage multiple organ systems, causing them to fail. The progression of sepsis can be rapid, and it requires prompt medical attention to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516849-39-01Protocol codeAPHP180596Estimated enrolment600 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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