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Comparing the efficacy and safety of extended (3 h) and intermittent infusion (0.5 h) of beta-lactams (cefepime, ceftriaxone, meropenem, piperacillin/tazobactam) in critically ill paediatric patients (PEBBLE)
EU CTIS ID: 2024-518115-19-02
What this study is testing
The objective of the study is to investigate the probability of target attainment of beta-lactams (100% fT>MIC, primary outcome) administering extended versus short-term intermittent infusion.
- 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
- paediatric patients (0-17 years of age) with suspected or proven bacterial infection being treated in a PICU or NICU and diagnosed with sepsis, i.e. a total Phoenix Sepsis Score≥2 points
- receiving β-lactams including meropenem, piperacillin/ tazobactam, cefepime, ceftazidime, ceftriaxone
- start of the same β-lactam therapy within the previous 24 hours or the start of a new β-lactam therapy because of clinical deterioration
- patients with normal or decreased estimated glomerular filtration rate (eGFR) if a dosage adjustment is not needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR>50 ml/min/1.73m2, in the case of ceftriaxone eGFR>10 mL/minute/1.73m2)
- ongoing infection is likely with or without culture positivity or confirmed infection: culture (haemoculture, cerebrospinal fluid, urine, from trachea, from wound, etc.) positivity, excluding contamination
- written informed consent by parent or guardian
You likely can't join if
- ≥18 years of age
- palliative patients
- patients enrolled in other medication studies
- patients with decreased renal function if dosage adjustment is needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR<50 ml/min/1.73m2, in the case of ceftriaxone eGFR<10 mL/minute/1.73m2)
- patients with Therapeutic Plasma Exchange (TPE)
- patients with extracorporeal therapy (continuous kidney replacement therapy [CKRT] or extracorporeal membrane oxygenation [ECMO])
See the full eligibility criteria
- paediatric patients (0-17 years of age) with suspected or proven bacterial infection being treated in a PICU or NICU and diagnosed with sepsis, i.e. a total Phoenix Sepsis Score≥2 points
- receiving β-lactams including meropenem, piperacillin/ tazobactam, cefepime, ceftazidime, ceftriaxone
- start of the same β-lactam therapy within the previous 24 hours or the start of a new β-lactam therapy because of clinical deterioration
- patients with normal or decreased estimated glomerular filtration rate (eGFR) if a dosage adjustment is not needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR>50 ml/min/1.73m2, in the case of ceftriaxone eGFR>10 mL/minute/1.73m2)
- ongoing infection is likely with or without culture positivity or confirmed infection: culture (haemoculture, cerebrospinal fluid, urine, from trachea, from wound, etc.) positivity, excluding contamination
- written informed consent by parent or guardian
- ≥18 years of age
- palliative patients
- patients enrolled in other medication studies
- patients with decreased renal function if dosage adjustment is needed (in the case of meropenem, cefepime, ceftazidime and piperacillin/tazobactam eGFR<50 ml/min/1.73m2, in the case of ceftriaxone eGFR<10 mL/minute/1.73m2)
- patients with Therapeutic Plasma Exchange (TPE)
- patients with extracorporeal therapy (continuous kidney replacement therapy [CKRT] or extracorporeal membrane oxygenation [ECMO])
- β-lactam allergy
- discontinued beta-lactam treatment within 3 days after randomisation
- referral from another institution or department with the same ongoing antibiotic treatment
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.