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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513890-30-00
Acronym
SePkLIN
Enrollment
692
Registered
2024-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

Incidence of thrombocytopenia. Thrombopenia will be considered to be a platelet count below 75% of the patient's baseline value, at any time during the follow-up period.

Detailed description

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.

Interventions

DRUGLINEZOLID

Sponsors

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of thrombocytopenia. Thrombopenia will be considered to be a platelet count below 75% of the patient's baseline value, at any time during the follow-up period.

Secondary

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026