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Study on Personalized Linezolid Dosing for Patients with Sepsis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying sepsis, a serious condition that occurs when the body's response to an infection causes injury to its own tissues and organs. The study will evaluate the use of a medication called linezolid, which is an antibiotic used to treat infections. Linezolid will be administered in two forms: as a solution for intravenous perfusion and as film-coated tablets taken orally. The purpose of the study is to compare the safety and effectiveness of personalized dosing of linezolid with standard dosing in patients with sepsis.

Participants in the study will receive either a personalized dose of linezolid, which is adjusted based on specific patient characteristics, or a standard dose. The study will monitor the occurrence of a condition called thrombocytopenia, which is a decrease in the number of platelets in the blood, as well as other outcomes such as the recurrence of infection, mortality rates, and the duration of hospital stays. The study will also track how well patients maintain therapeutic levels of the medication in their system.

The trial will last for a period of up to 28 days, during which various health parameters will be observed. These include the number of days patients are free from treatments like mechanical ventilation and renal replacement therapy, as well as their progress on the SOFA scale, which measures the extent of a person's organ function or rate of failure. The study aims to provide valuable insights into the best dosing strategies for linezolid in treating sepsis, potentially improving patient outcomes and safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria: being an adult (18 years or older) diagnosed with sepsis and already receiving linezolid as part of standard treatment.

  2. Step 2

    Treatment administration

    Linezolid is administered either intravenously or orally. The study compares personalized dosing based on specific patient characteristics with standard dosing.

  3. Step 3

    Monitoring and evaluation

    The primary focus is on the occurrence of thrombocytopenia, which is a decrease in platelet count to below 75% of the baseline value.

    Secondary evaluations include the recurrence of infection, mortality rates at 14 and 28 days, changes in the SOFA scale (a measure of organ function), and the duration of stay in the critical care unit.

  4. Step 4

    Follow-up period

    The follow-up period includes monitoring for recurrence of infection up to day 28, assessing the number of days free from treatments such as vasopressor agents, mechanical ventilation, renal replacement therapy, and extracorporeal therapy.

    The percentage of patients achieving the target therapeutic range and specific pharmacokinetic/pharmacodynamic parameters is also evaluated.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by November 3, 2025. The results will contribute to understanding the effectiveness and safety of personalized dosing of linezolid in treating sepsis.

Who can join the trial?

6 criteria

  • Adult patients who are **18 years or older**.
  • Patients who are receiving **linezolid**, which is a type of antibiotic medication.
  • Patients who have been diagnosed with **sepsis**. Sepsis is a serious condition that happens when the body has a strong reaction to an infection.
  • For the diagnosis of sepsis, patients should have a **SOFA scale** score of 2 points or more. The SOFA scale is a way to measure how well a person's organs are working.
  • If a patient has a long-term organ problem, their SOFA score should have increased by 2 points compared to their usual score.
  • Patients must have already started treatment with linezolid as part of their regular medical care.

Who cannot join the trial?

10 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have a medical condition that is not compatible with the study requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a medical condition that could interfere with the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a serious illness that could affect their ability to participate in the study.
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Investigated drugs

Linezolid: This medication is an antibiotic used to treat serious bacterial infections. In this clinical trial, the focus is on comparing two different dosing strategies for linezolid in patients with sepsis. The study aims to determine if personalized dosing, which is adjusted based on the patient's specific drug levels and response, is safer and more effective than the standard dosing approach. The main goal is to see if personalized dosing can reduce the risk of thrombocytopenia, a condition where there is a lower than normal number of platelets in the blood, which can lead to increased bleeding and bruising.

What is already known about the treatment

Linezolid – Linezolid is administered orally or intravenously and is currently used in medical practice, with ongoing research to optimize its dosing. It is primarily indicated for the treatment of infections caused by certain bacteria, including those associated with sepsis. Linezolid works by inhibiting bacterial protein synthesis, which prevents bacteria from growing and multiplying. It belongs to the pharmacological class of oxazolidinone antibiotics.

Investigated diseases

Sepsis – Sepsis is a severe medical condition that arises when the body's response to infection causes widespread inflammation. This inflammation can lead to tissue damage, organ failure, and other serious complications. It typically begins with an infection in one part of the body, such as the lungs, urinary tract, or skin, and can spread through the bloodstream. As the condition progresses, it can cause a drop in blood pressure, leading to septic shock. Symptoms may include fever, increased heart rate, rapid breathing, and confusion. Early recognition and management are crucial to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513890-30-00Protocol codeSePkLINEstimated enrolment692 patientsSponsorFundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

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