AMOXICILLIN SODIUM for Systemic infections

Inclusion criteria

• {"criterion_text":"- Subject aged between 0 - 17 years 10 months"}
• {"criterion_text":"- Subject admitted to a participating ward unit (NICU, PICU, PHO unit)"}
• {"criterion_text":"- Strongly suspected or confirmed systemic infection"}
• {"criterion_text":"- Subject planned to start on intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem treatment at least aimed for a minimum duration of two days at time of inclusion. If the subject was previously treated with the same beta-lactam, the minimum interval to the previous beta-lactam treatment episode is 40 hours for amoxicillin-clavulanic acid (based on elimination half-life) and 8 hours for piperacillin-tazobactam and meropenem (based on elimination half-life)"}
• {"criterion_text":"- Informed consent/assent signed by parents or legal representatives of the subject."}
• {"criterion_text":"- Not previously enrolled in this trial"}

Exclusion criteria

• {"criterion_text":"- Subject with serum creatinine level ≥ 2 mg/L at inclusion."}
• {"criterion_text":"- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique"}
• {"criterion_text":"- Subject receiving (or planned to receive) body cooling"}
• {"criterion_text":"- Subject death is deemed imminent and inevitable"}
• {"criterion_text":"- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours after start treatment"}
• {"criterion_text":"- The subject is known or suspected to be pregnant"}
• {"criterion_text":"- The subject has a known allergy to the specific beta-lactam antibiotic"}

Primary endpoints

• {"endpoint_text":"- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 48 hours after start of beta-lactam treatment","definition_or_measurement_approach":"Measured as the proportion of subjects attaining the therapeutic target 100% fT>MIC at 48 hours after start of treatment, assessed using antibiotic concentration measurements in blood and the relevant MIC."}

Secondary endpoints

• {"endpoint_text":"- Proportion of subjects reaching the therapeutic target 100% fT>MIC at 120 hours after start of treatment","definition_or_measurement_approach":"Measured as the proportion of subjects attaining 100% fT>MIC at 120 hours after start of treatment, assessed using antibiotic concentration measurements in blood and the relevant MIC."}
• {"endpoint_text":"- Proportion of subjects reaching the therapeutic target 100% fT>MIC within the interval 48 to 72 hours after start of treatment","definition_or_measurement_approach":"Measured as the proportion of subjects attaining 100% fT>MIC within 48–72 hours after treatment start, assessed using antibiotic concentration measurements in blood and the relevant MIC."}
• {"endpoint_text":"- Hospital length-of-stay","definition_or_measurement_approach":"Measured as duration of hospitalisation (length-of-stay) as recorded in the patient record."}

Methods

• Recruitment from participating ward units (NICU, PICU, PHO unit) at participating hospitals; target audience critically ill children (aged 0 to 17 years 10 months) who are planned to start intravenous amoxicillin-clavulanic acid, piperacillin-tazobactam or meropenem.

Belgium

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

07-11-2024

Processing Time Days

17

Number Of Sites

1

Number Of Participants

58

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium