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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.
EU CTIS ID: 2024-513890-30-00
What this study is testing
The primary objective of the study is to demonstrate the superiority of personalized linezolid dosing based on PK/PD by evaluating the incidence of thrombocytopenia in both treatment groups.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (18 years and older) receiving linezolid.
- Diagnosis of sepsis (SOFA scale ≥ 2 points or in the case of chronic organ dysfunction, increase of 2 points compared to the baseline score).
- Patients have started antibiotic treatment with linezolid according to usual clinical practice.
You likely can't join if
- Interruption of treatment before the first blood sample.
- Pregnant or nursing women.
- Known allergy or hypersensitivity to linezolid.
- Patients will be excluded if they are already in any other intervention trials.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.