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Study of Amoxicillin-clavulanic acid, Piperacillin-tazobactam and Meropenem dosing in critically ill children with systemic infections

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What is this trial about?

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

This study focuses on treating systemic infections in critically ill children using three different antibiotics: amoxicillin-clavulanic acid, piperacillin-tazobactam, and meropenem. These medications are given through an intravenous line directly into the bloodstream to fight serious infections throughout the body.

The purpose of this research is to examine how well these antibiotics work when their dosing is guided by a special calculation method in critically ill children. The study will use precise measurements to determine if the right amount of medicine is reaching the infection. Each participant will receive one of the three antibiotics for up to 8 weeks of treatment.

During the study, doctors will monitor how the antibiotics work in the body by taking blood samples at different times. This helps ensure that enough medicine is present in the body to fight the infection effectively. The treatment approach being studied aims to provide more accurate dosing of these important medications for young patients who are seriously ill.

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

    Initial treatment start

    You will receive one of three intravenous antibiotics: amoxicillin-clavulanic acid, piperacillin-tazobactam, or meropenem

    The treatment will be administered through a vein for at least two days

    The medical team will select the most appropriate antibiotic based on your infection

  2. Step 2

    48-hour evaluation

    The medical team will evaluate how well the antibiotic is working in your body after the first 48 hours of treatment

    Blood samples may be taken to check the effectiveness of the treatment

  3. Step 3

    48-72 hour period

    The treatment continues with regular monitoring

    The medical team will assess if the antibiotic levels are appropriate for fighting the infection

  4. Step 4

    120-hour assessment

    A final evaluation of the antibiotic effectiveness will be conducted after 120 hours (5 days) of treatment

    The medical team will determine if any adjustments to the treatment are needed

  5. Step 5

    Ongoing care

    Treatment will continue as long as medically necessary

    Your hospital stay duration will be monitored and recorded

    Regular assessments will continue until you are ready to be discharged

Who can join the trial?

7 criteria

  • Age requirement: Children between birth and 17 years and 10 months old
  • Must be admitted to one of these hospital units: NICU (Newborn Intensive Care Unit), PICU (Pediatric Intensive Care Unit), or PHO (Pediatric Hematology-Oncology) unit
  • Must have either a confirmed or strongly suspected systemic infection (infection that affects multiple parts of the body)
  • Must be scheduled to receive one of these antibiotics through an IV (intravenous line): - Amoxicillin-clavulanic acid - Piperacillin-tazobactam - Meropenem Treatment must be planned for at least 2 days
  • If previously treated with the same antibiotic, there must be a waiting period: - 40 hours for amoxicillin-clavulanic acid - 8 hours for piperacillin-tazobactam or meropenem
  • Parents or legal guardians must sign an informed consent form
  • Must not have participated in this study before

Who cannot join the trial?

11 criteria

  • Age below 6 months or above 18 years
  • Known allergic reactions to beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, or meropenem)
  • Patients receiving continuous renal replacement therapy (a treatment that helps filter waste from the blood when kidneys are not working properly)
  • Patients with severe kidney failure (poor kidney function)
  • Patients receiving extracorporeal membrane oxygenation (ECMO - a treatment that uses a machine to perform the work of the lungs and sometimes the heart)
  • Patients who have received the study antibiotics for more than 24 hours before potential enrollment
  • Legal guardian unable or unwilling to provide informed consent
  • Previous participation in this study
  • Participation in another interventional clinical trial
  • Expected length of antibiotic treatment less than 48 hours
  • Presence of conditions that might interfere with the study procedures or evaluation
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Investigated drugs

  • Amoxicillin-clavulanic acid

    is an antibiotic combination medication. It belongs to the beta-lactam family of antibiotics. The amoxicillin component fights bacterial infections, while clavulanic acid helps prevent bacteria from becoming resistant to amoxicillin. It's commonly used to treat various types of bacterial infections in critically ill patients.

  • Piperacillin-tazobactam

    is a combination antibiotic medication. Piperacillin is a powerful antibiotic that fights many types of bacteria, while tazobactam prevents bacteria from developing resistance to piperacillin. This combination is often used in serious infections, particularly in hospital settings and for critically ill patients.

  • Meropenem

    is a broad-spectrum antibiotic that belongs to the carbapenem family. It works by preventing bacteria from forming their cell walls, which kills the bacteria. It's typically reserved for serious infections and is commonly used in intensive care settings to treat severe bacterial infections.

What is already known about the treatment

  • Amoxicillin-clavulanic acid

    An oral or intravenous antibiotic combination medication consisting of amoxicillin and clavulanic acid, commonly used to treat various bacterial infections. This beta-lactam antibiotic works by preventing bacteria from forming cell walls while the clavulanic acid component protects the amoxicillin from being broken down by bacterial enzymes. The medication is particularly effective against a broad spectrum of bacteria and is frequently prescribed for systemic infections in both adults and children.

  • Piperacillin-tazobactam

    An intravenous antibiotic combination that pairs piperacillin, a broad-spectrum penicillin, with tazobactam, which protects against certain bacterial resistance mechanisms. This medication is primarily used in hospital settings for treating severe systemic infections, working by interfering with bacterial cell wall synthesis. It is particularly valuable in critical care situations due to its broad coverage against many types of bacteria, including resistant strains.

  • Meropenem

    A powerful broad-spectrum antibiotic administered intravenously, belonging to the carbapenem class of antibiotics. It works by penetrating bacterial cell walls and preventing their synthesis, effectively treating severe systemic infections in critically ill patients. This medication is often reserved for serious infections or when other antibiotics have failed, and it maintains effectiveness against many resistant bacteria commonly found in hospital settings.

Investigated diseases

Systemic Infection - A condition where harmful microorganisms spread throughout the body via the bloodstream, affecting multiple organs and systems simultaneously. The infection begins when pathogens enter the blood circulation and multiply, causing a body-wide inflammatory response. This type of infection can involve various types of pathogens, including bacteria, viruses, or fungi. Systemic infections typically cause general symptoms like fever, fatigue, and overall feeling of illness. The body's immune system responds by activating multiple defense mechanisms to fight the spreading infection.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516447-12-00Protocol codeMOMENTUM trialEstimated enrolment58 patientsSponsorUniversitair Ziekenhuis Gent

sourced from the EU Clinical Trials Register and site verification

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