Ongoing Clinical Trials for Systemic Infection
There is currently 1 ongoing clinical trial investigating antibiotic dosing strategies for systemic infections in critically ill children. This trial is testing three different beta-lactam antibiotics with the goal of improving treatment precision through careful monitoring of drug levels in the bloodstream.
Clinical trial locations
Study of Amoxicillin-clavulanic acid, Piperacillin-tazobactam and Meropenem dosing in critically ill children with systemic infections
This trial focuses on improving the way antibiotics are given to critically ill children with infections that have spread throughout the body. The study examines three different antibiotics to determine if using precise calculations to guide dosing can help ensure that the right amount of medicine reaches the infection site.
Who can participate:
- Children from newborns up to 17 years and 10 months old
- Patients admitted to a Newborn Intensive Care Unit, Pediatric Intensive Care Unit, or Pediatric Hematology-Oncology unit
- Children with confirmed or strongly suspected infection affecting multiple parts of the body
- Those scheduled to receive one of the three study antibiotics through an IV for at least 2 days
- If previously treated with the same antibiotic, there must be a waiting period of either 40 hours for amoxicillin-clavulanic acid or 8 hours for the other two antibiotics
- Parents or legal guardians must provide written consent
- Children who have not participated in this study before
Who cannot participate:
- Children younger than 6 months or 18 years and older
- Anyone with known allergic reactions to beta-lactam antibiotics
- Patients receiving continuous renal replacement therapy or with severe kidney failure
- Patients on ECMO treatment, which is a machine that performs the work of the lungs and sometimes the heart
- Those who have already received the study antibiotics for more than 24 hours
- Situations where the legal guardian cannot or will not provide consent
- Previous participants in this study or those enrolled in another interventional trial
- Cases where antibiotic treatment is expected to last less than 48 hours
- Presence of conditions that might interfere with study procedures
What the trial involves:
The main goal of this research is to test whether using precise measurement methods to guide antibiotic dosing improves treatment outcomes in critically ill children. Participants will receive one of three antibiotics directly into their bloodstream through an IV line. The medical team will monitor how the antibiotic works in the body by taking blood samples at specific time points during treatment. This approach aims to ensure that enough medicine is present in the body to effectively fight the infection.
Treatment begins with the administration of the selected antibiotic, which continues for at least two days. The medical team evaluates the antibiotic’s effectiveness after 48 hours by checking blood samples. Monitoring continues through 72 hours and again at 120 hours (5 days) to assess whether the antibiotic levels are appropriate. Treatment continues as long as medically necessary, with ongoing assessments until the child is ready to be discharged from the hospital.
Investigational drugs:
Amoxicillin-clavulanic acid is a combination antibiotic from the beta-lactam family. The amoxicillin component fights bacterial infections, while clavulanic acid helps prevent bacteria from becoming resistant to the treatment. This combination is commonly used to treat various bacterial infections in critically ill patients.
Piperacillin-tazobactam is another combination antibiotic where piperacillin fights many types of bacteria and tazobactam prevents bacterial resistance. This powerful medication is often used in hospital settings for serious infections, particularly in critically ill patients.
Meropenem is a broad-spectrum antibiotic belonging to the carbapenem family. It works by preventing bacteria from forming their cell walls, which destroys the bacteria. This medication is typically reserved for serious infections and is commonly used in intensive care settings to treat severe bacterial infections.
Summary
Currently, there is one active clinical trial investigating optimal antibiotic dosing for systemic infections in critically ill children. The trial is being conducted in Belgium and focuses specifically on pediatric patients in intensive care settings. All three investigational drugs being studied belong to the beta-lactam antibiotic class, reflecting the importance of these medications in treating serious bacterial infections. The study emphasizes precision in dosing by using blood level monitoring to ensure adequate drug concentrations are achieved. This approach represents an important step toward personalizing antibiotic treatment for the most vulnerable young patients with life-threatening infections.