critically ill patients infections
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: All patients admitted to the pediatric intensive care unit wards and given standard of care intravenous therapy of target antibiotic are screened for participating trial. Antibiotic initiation based on clinical suspicion of infection and/or cultured pathogens susceptible to the target drugs, initial dosage prescription, and duration of therapy are at the discretion of the attending physician. In order to be eligible to participate in this study a subject must also meet all the followinng criteria: • Written informed consent has been obtained from the patient or their legally authorized representative. • Recruitment within 36 hours after start of antibiotic therapy • Intravenous antibiotic therapy of the target antibiotic should be aimed for at least 2 days.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Premature infants • History of anaphylaxis for the study antibiotics • Consent not obtained • Study antibiotic cessation before blood collection • Prophylactic use of the study antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PK/PD endpoints are the unbound concentration above the MIC at 100% (PICU target) of the dosing interval (*T*>*MICECOFF and *T*>*4 x MICECOFF). The percentage *T*>*MIC is determined by calculating the intercept of the MIC values with the concentration-time curve. The following PK/PD indices are calculated: • %*T>MICECOFF for each individual patient • % of patients that achieved the target of 100% *T>MICECOFF and 100% *T>4×MICECOFF • Target attainment for the study antibiotics and dosing regimens to reach the target of 100% *T*>*MIC and 100% *T*>*4×MIC for a range of MICs (0.03125 to 128* mg/L) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are estimated multivariate binomial and binary logistic regression models, to examining the association of target attainment with patient characteristics and clinical outcomes. We defined ICU length of stay (LOS) from the start of therapy (enrollment) as a secondary endpoint. Factors likely to contribute to these two outcomes were analyzed for association based on clinical relevancy and previously described relationships (11). These included patient characteristics (age, gender, body mass index (BMI)), organ dysfunction score (PELOD), serum albumin, serum urea, sepsis, estimated glomerular filtration rate (eGFR >= 90 mL/min/1.73 m2), and presence of extracorporeal circuits (CRRT (continuous renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). | — |
Countries
Netherlands
Outcome results
None listed