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

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What is this study about?

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.

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 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 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

4 120-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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.11.2024

Trial locations

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.

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 ID:
2024-516447-12-00
Protocol code:
MOMENTUM trial
Trial Phase:
Therapeutic confirmatory (Phase III)

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