BridgeMD
Early Model-Informed Precision Dosing of beta-lactam antibiotics in critically ill children: big solution for small people?
EU CTIS ID: 2024-516447-12-00
What this study is testing
To investigate the impact of early MIPD-guided dosing on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and meropenem) in critically ill children.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject aged between 0 - 17 years 10 months
- Subject admitted to a participating ward unit (NICU, PICU, PHO unit)
- Strongly suspected or confirmed systemic infection
- 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)
- Informed consent/assent signed by parents or legal representatives of the subject.
- Not previously enrolled in this trial
You likely can't join if
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique
- Subject receiving (or planned to receive) body cooling
- Subject death is deemed imminent and inevitable
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours after start treatment
- The subject is known or suspected to be pregnant
See the full eligibility criteria
- Subject aged between 0 - 17 years 10 months
- Subject admitted to a participating ward unit (NICU, PICU, PHO unit)
- Strongly suspected or confirmed systemic infection
- 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)
- Informed consent/assent signed by parents or legal representatives of the subject.
- Not previously enrolled in this trial
- Subject with serum creatinine level ≥ 2 mg/L at inclusion.
- Subject receiving (or planned to receive) haemofiltration, extracorporeal membrane oxygenation, hemodialysis or peritoneal dialysis, molecular adsorbent recirculating system or any other exchange technique
- Subject receiving (or planned to receive) body cooling
- Subject death is deemed imminent and inevitable
- Reporting of first dosing advice (based on blood sampling) is not possible within 28 hours after start treatment
- The subject is known or suspected to be pregnant
- The subject has a known allergy to the specific beta-lactam antibiotic
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.