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Study on the Effectiveness and Safety of Extended vs. Intermittent Infusion of Meropenem in Critically Ill Children with Suspected or Proven Infection

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 focuses on critically ill pediatric patients with suspected or proven infections who are being treated in pediatric or neonatal intensive care units. The study aims to compare two different methods of administering beta-lactam antibiotics - extended infusion (3 hours) versus intermittent infusion (30 minutes). The specific antibiotics being studied include cefepime, ceftazidime, ceftriaxone, meropenem, and piperacillin/tazobactam.

The purpose of this study is to investigate whether the duration of antibiotic infusion affects how well the medication reaches and maintains effective levels in the bloodstream of children. Participants will be randomly assigned to receive their prescribed antibiotic either through the extended infusion method or the shorter intermittent infusion method. During the study, blood samples will be collected to measure the concentration of the antibiotic in the blood, and various indicators of infection and recovery will be monitored.

The study will track several outcomes including how quickly infection markers in the blood return to normal, how long patients need to stay in the intensive care unit, and whether any side effects occur. This research could help determine the most effective way to administer these important antibiotics to critically ill children.

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 PEBBLE study

    After providing consent to participate in the study, you will be randomly assigned to one of two groups: either the extended infusion group (3-hour infusion) or the intermittent infusion group (30-minute infusion).

    You will receive one of the beta-lactam antibiotics (cefepime, ceftazidime, ceftriaxone, meropenem, or piperacillin/tazobactam) as part of your treatment for suspected or confirmed infection.

    The antibiotic treatment will have started within the previous 24 hours before entering the study, or you may be starting a new antibiotic treatment due to clinical deterioration.

  2. Step 2

    Antibiotic administration

    Depending on which group you are assigned to, you will receive your antibiotic medication through an intravenous (IV) line either over 3 hours (extended infusion) or over 30 minutes (intermittent infusion).

    The dosage and frequency of the antibiotic will be determined by your doctor based on your specific condition, weight, and kidney function.

    The antibiotic treatment will continue for as long as medically necessary for your infection.

  3. Step 3

    Blood sampling

    Blood samples will be collected to measure the concentration of the antibiotic in your blood.

    These samples will primarily be taken at the trough level (just before the next dose is given) to determine if the antibiotic is reaching effective levels in your body.

  4. Step 4

    Monitoring of infection markers

    Throughout your treatment, several markers will be monitored to track your response to the antibiotics:

    CRP (C-reactive protein): A blood test that measures inflammation in your body

    PCT (Procalcitonin): A blood test that helps determine the severity of bacterial infections

    WBC (White Blood Cell count): A blood test that measures your body's immune response to infection

    Microbiological tests will be performed on days 1, 2, 3, and 5 to check if the infection-causing bacteria are still present

  5. Step 5

    Clinical assessment

    Your clinical response to the antibiotic treatment will be assessed daily.

    Doctors will check for improvement in your symptoms, vital signs, and overall condition.

    Any side effects or adverse events will be documented every day during your treatment.

  6. Step 6

    Follow-up

    You will be monitored for up to 30 days or until hospital discharge, whichever comes first.

    The study will track how many days you spend in the intensive care unit (PICU/NICU) and your total hospital stay length.

    If the antibiotic treatment isn't working effectively, your doctor may change your treatment as needed.

Who can join the trial?

7 criteria

  • Child or teen (0-17 years old) who is hospitalized in a pediatric intensive care unit (PICU) or neonatal intensive care unit (NICU)
  • Child has a suspected or proven infection (shown by positive culture from blood, spinal fluid, urine, throat, wound, etc.)
  • Currently receiving certain antibiotics (meropenem, piperacillin/tazobactam, cefepime, ceftazidime, or ceftriaxone) for less than 24 hours, or starting a new antibiotic due to worsening condition
  • Child has normal or slightly decreased kidney function (measured by estimated glomerular filtration rate or eGFR)
  • For most antibiotics in the study (meropenem, cefepime, ceftazidime, piperacillin/tazobactam), kidney function must be greater than 50 ml/min/1.73m²
  • For ceftriaxone, kidney function must be greater than 10 ml/min/1.73m²
  • Parent or guardian must provide written informed consent for the child to participate

Who cannot join the trial?

2 criteria

  • You cannot participate if you have a critical illness (a severe medical condition that requires intensive care and may be life-threatening)
  • You cannot participate if you have a suspected or proven infection (when doctors either think you might have or have confirmed you have an infection caused by bacteria, viruses, or other organisms)
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Investigated drugs

Beta-lactam antibiotics - This group of medications includes cefepime, ceftazidime, ceftriaxone, meropenem, and piperacillin/tazobactam. These are antibiotics used to treat bacterial infections. In this study, they are being given in two different ways: as an extended 3-hour infusion or as a shorter 30-minute infusion. The researchers are studying which method of giving these antibiotics works better for critically ill children.

What is already known about the treatment

  • Cefepime

    A beta-lactam antibiotic administered through intravenous infusion, either as an extended 3-hour infusion or a shorter 30-minute intermittent infusion in critically ill patients with suspected or proven infections. It works by binding to penicillin-binding proteins in bacterial cell walls, inhibiting cell wall synthesis and causing bacterial cell death. Cefepime is classified as a fourth-generation cephalosporin and is primarily used to treat severe infections, including pneumonia, urinary tract infections, and sepsis, particularly in critical care settings where optimal drug concentration over time is crucial for therapeutic success.

  • Ceftazidime

    An injectable beta-lactam antibiotic that can be administered as either an extended 3-hour infusion or a shorter 30-minute intermittent infusion for critically ill patients with suspected or proven infections. It functions by inhibiting bacterial cell wall synthesis by binding to specific proteins, causing structural weakness and eventual cell rupture. Ceftazidime is a third-generation cephalosporin particularly effective against Pseudomonas aeruginosa and other gram-negative bacteria, making it valuable for treating severe respiratory, urinary, and bloodstream infections in intensive care settings.

  • Ceftriaxone

    A beta-lactam antibiotic administered intravenously either as an extended 3-hour infusion or a standard 30-minute intermittent infusion in critically ill patients with infections. It works by interfering with bacterial cell wall synthesis, binding to penicillin-binding proteins and preventing proper cell wall formation, which leads to bacterial cell death. Ceftriaxone is a third-generation cephalosporin widely used in treating serious infections including meningitis, pneumonia, and complicated urinary tract infections due to its broad-spectrum activity and relatively long half-life.

  • Meropenem

    A broad-spectrum antibiotic administered through intravenous infusion, either as an extended 3-hour or shorter 30-minute intermittent infusion in critically ill patients with suspected or confirmed infections. It belongs to the carbapenem class of antibiotics and works by penetrating bacterial cell walls and inhibiting cell wall synthesis, leading to cell death. Meropenem is used for treating serious infections including intra-abdominal infections, pneumonia, and sepsis, particularly those caused by multi-drug resistant organisms, and has good penetration into various tissues including the central nervous system.

  • Piperacillin/Tazobactam

    A combination antibiotic administered intravenously either as an extended 3-hour infusion or a standard 30-minute intermittent infusion in critically ill patients with suspected or proven infections. This medication pairs piperacillin (a penicillin antibiotic) with tazobactam (a beta-lactamase inhibitor) that prevents bacterial enzymes from breaking down piperacillin, enhancing its effectiveness against resistant bacteria. Classified as an extended-spectrum penicillin combination, it's widely used for treating complicated intra-abdominal infections, pneumonia, and severe sepsis, particularly when Pseudomonas aeruginosa or other resistant gram-negative infections are suspected.

Investigated diseases

  • Critical Illness

    A severe medical condition that impairs one or more vital organ systems, putting the patient at imminent risk of deterioration and death. It often requires intensive care management and monitoring with advanced life support equipment. Critical illness frequently involves significant physiological derangements affecting multiple organ systems simultaneously. The condition typically develops as a result of severe injury, major surgery, or acute medical conditions. Critical illness may lead to a systemic inflammatory response that can worsen organ dysfunction. Recovery from critical illness often involves a prolonged rehabilitation period.

  • Infection

    The invasion and multiplication of pathogenic microorganisms such as bacteria, viruses, fungi, or parasites within body tissues. Infections trigger an immune response that typically causes inflammation and characteristic symptoms including fever, increased white blood cell count, and specific symptoms related to the infected organ system. Infections can be localized to a specific body part or spread throughout the body via the bloodstream (sepsis). They range in severity from mild and self-limiting to severe and life-threatening. Infections can progress from colonization to invasion of tissues, potentially leading to organ dysfunction if left untreated. The body's response to infection can sometimes cause more damage than the infectious agent itself.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518115-19-02Protocol codePEBBLEEstimated enrolment110 patientsSponsorSemmelweis University

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