critical illness, suspected or proven infection
Conditions
Brief summary
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.
Detailed description
The proportion of patients achieving PK/PD index: 100% fT>4xMIC (Ctrough >4xMIC), CRP normalisation (days, <10 mg/L), PCT normalisation (days, <0.5), WBC normalisation (days, <10000 /µl), All-cause mortality (within 30 days or until hospital discharge), Adverse events (every day), Microbiological eradication rate (in different time points: 1st day, 2nd day, 3rd day, 5th day), Clinical response (resolution or improvement or failure), Clinical success (Time in days when clinical succes or resolution is achieved), Treatment failure (Number of patients, for whom the β-lactam antibiotic had to be stopped due to the clinical deterioration and/or antibiotic resistance.), Duration of the antibiotic (days), Length of PICU/NICU stay (days), Length of hospital stay (LOS) (days)
Interventions
DRUGMeropenem Qilu 1 g por oldatos injekcióhoz/infúzióhoz
DRUGMeropenem Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUG5 g por oldatos infúzióhoz
DRUGCeftriaxon MIP 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxon MIP 2 g por oldatos infúzióhoz
DRUGMeropenem Steriscience 1000 mg por oldatos injekciohoz vagy infuziohoz
DRUGMeropenem Qilu 500 mg por oldatos injekcióhoz/infúzióhoz
DRUGCefepim AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxone Qilu 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxon AptaPharma 2 g por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem Kabi 500 mg por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxone Kalceks 2 g por oldatos injekcióhoz vagy inf?zióhoz
DRUGCeftriaxone Qilu 2 g por oldatos injekcióhoz vagy infúzióhoz
DRUGPiperacillin/Tazobactam Sandoz 4 g/0
DRUGMeropenem Steriscience 500 mg por oldatos injekciohoz vagy infuziohoz
DRUGCeftriaxon Kabi 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxon AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGCefepim AptaPharma 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem AptaPharma 1000 mg por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem Kalceks 500 mg por oldatos injekcióhoz vagy infúzióhoz
DRUGCeftriaxone Kalceks 1 g por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem AptaPharma 500 mg por oldatos injekcióhoz vagy infúzióhoz
DRUGPiperacillin/Tazobactam Kalceks 4 g/0
DRUGCeftriaxon Kabi 2 g por oldatos infúzióhoz
DRUGMeropenem AptaPharma 2000 mg por oldatos infúzióhoz
DRUGMeropenem Pharmacenter 500 mg por oldatos injekcióhoz vagy infúzióhoz
DRUGMeropenem Pharmacenter 1 g por oldatos injekcióhoz vagy infúzióhoz
Sponsors
Semmelweis University
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving PK/PD index: 100% fT>4xMIC (Ctrough >4xMIC), CRP normalisation (days, <10 mg/L), PCT normalisation (days, <0.5), WBC normalisation (days, <10000 /µl), All-cause mortality (within 30 days or until hospital discharge), Adverse events (every day), Microbiological eradication rate (in different time points: 1st day, 2nd day, 3rd day, 5th day), Clinical response (resolution or improvement or failure), Clinical success (Time in days when clinical succes or resolution is achieved), Treatment failure (Number of patients, for whom the β-lactam antibiotic had to be stopped due to the clinical deterioration and/or antibiotic resistance.), Duration of the antibiotic (days), Length of PICU/NICU stay (days), Length of hospital stay (LOS) (days) | — |
Countries
Hungary
Outcome results
None listed