SePkLin Study: Pragmatic, Multicenter, Randomized, Controlled Clinical Trial in Patients with Sepsis to Evaluate the Safety and Efficacy of Personalized Pk/Pd Dosing Versus Standard Dosing of LINezolid.

简要总结

主要结局

次要结局

• Recurrence rate (relapses and reinfections) up to day 28: Recurrence is defined as the reappearance of symptoms of infection together with a positive culture for the same microorganism isolated in the initial culture in a patient with clinical cure at the cure visit. Reinfection is defined in a similar way, but with isolation of a different strain from the initial one.
• Mortality: mortality from all causes will be evaluated at 14 and 28 days.
• Changes in the SOFA scale: evolution of the daily values ​​in the SOFA scale.
• Duration of admission to the critical care unit: number of days from admission to the critical care unit until being discharged from the unit.
• Days free from treatment with vasopressor agents: number of days that the patient avoided receiving vasopressor agents.
• Days free from mechanical ventilation: number of days that the patient avoided mechanical ventilation.
• Renal Replacement Therapy Free Days: Number of days the patient avoided renal replacement therapy.
• Days free of extracorporeal therapy: number of days that the patient avoided the use of extracorporeal membrane oxygenation.
• Percentage of patients in therapeutic range: the percentage of patients in therapeutic range will be evaluated, 2-7 mg/L
• Percentage of patients achieving the target PK/PD parameter: the percentage of patients achieving the target PK/PD parameter of AUC0 →24h/MIC ≥100 and %T>MIC will be evaluated. When microbiological culture and its corresponding MIC are not available, the ECOFF value defined by EUCAST will be used.