Sepsis in children Pediatric sepsis, sepsis, septic shock, meropenem, beta-lactam antibiotics, continuous infusion, extended infusion, pediatric intensive care unit, randomized controlled trial
Conditions
Interventions
Meropenem 40 mg/kg/dose (maximum 2 g) administered as continuous intravenous infusion over 24 hours with solution replacement every 8 hours,Meropenem 40 mg/kg/dose (maximum 2 g) administered every 8 h
Experimental Drug,Active Comparator Drug
Continuous infusion meropenem,Extended infusion meropenem
Sponsors
Faculty of Pharmacy Universitas Indonesia
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: Pediatric patients aged 1 month to 18 years admitted to the PICU with sepsis receiving meropenem therapy with informed consent from parents or legal guardians and assent from children aged 12 to 18 years when appropriate
Exclusion criteria
Exclusion criteria: Hypersensitivity to meropenem, culture-confirmed meropenem-resistant infection, eGFR <50 mL/min, immunodeficiency or immunosuppressive therapy, and incomplete or unknown vaccination status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure End of meropenem therapy Resolution or improvement of infection signs and symptoms without antibiotic escalation or death during treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause in-hospital mortality Until hospital discharge Death from any cause during hospitalization.,Duration of meropenem therapy During hospitalization Total duration of meropenem administration in days. | — |
Countries
Indonesia
Contacts
Public ContactChairul Isa
Faculty of Pharmacy, Universitas Indonesia
Outcome results
None listed