MEROPENEM for Bacterial infection | Critical illness

Inclusion criteria

• {"criterion_text":"- 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\n- receiving β-lactams including meropenem, piperacillin/ tazobactam, cefepime, ceftazidime, ceftriaxone\n- 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\n- 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)\n- 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\n- written informed consent by parent or guardian"}

Exclusion criteria

• {"criterion_text":"- ≥18 years of age\n- palliative patients\n- patients enrolled in other medication studies\n- 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)\n- patients with Therapeutic Plasma Exchange (TPE)\n- patients with extracorporeal therapy (continuous kidney replacement therapy [CKRT] or extracorporeal membrane oxygenation [ECMO])\n- β-lactam allergy\n- discontinued beta-lactam treatment within 3 days after randomisation\n- referral from another institution or department with the same ongoing antibiotic treatment"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients achieving the therapeutic and optimal exposure when the plasma concentrations are above the MIC for 100% of the dosing interval. Trough plasma concentration levels will be measured.","definition_or_measurement_approach":"Therapeutic exposure defined as plasma concentrations above the MIC for 100% of the dosing interval; trough plasma concentration levels will be measured."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients achieving PK/PD index: 100% fT>4xMIC (Ctrough >4xMIC)\n- CRP normalisation (days, <10 mg/L)\n- PCT normalisation (days, <0.5)\n- WBC normalisation (days, <10000 /µl)\n- All-cause mortality (within 30 days or until hospital discharge)\n- Adverse events (every day)\n- Microbiological eradication rate (in different time points: 1st day, 2nd day, 3rd day, 5th day)\n- Clinical response (resolution or improvement or failure)\n- Clinical success (Time in days when clinical succes or resolution is achieved)\n- Treatment failure (Number of patients, for whom the β-lactam antibiotic had to be stopped due to the clinical deterioration and/or antibiotic resistance.)\n- Duration of the antibiotic (days)\n- Length of PICU/NICU stay (days)\n- Length of hospital stay (LOS) (days)","definition_or_measurement_approach":"Endpoints include PK/PD indices (e.g. 100% fT>4xMIC measured by trough concentrations), biomarker normalisation thresholds (CRP <10 mg/L; PCT <0.5), WBC <10000/µl, timebound mortality (30 days or until discharge), daily adverse event monitoring, microbiological sampling at specified days (1,2,3,5), clinical response/success definitions as per protocol, duration metrics in days, and lengths of stay in days."}

Hungary

Earliest CTIS Part Ii Submission Date

30-04-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

152

Number Of Sites

2

Number Of Participants

110

Primary sponsor

Full Name

Semmelweis University

Organisation Type

Educational Institution

Country Of Registered Address

Hungary