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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

completed 4 Mar 2026

Decision date (initial)

2024-08-02

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Instituto de Salud Carlos III (ICI21/00043)

External identifiers

EU CT number

2024-513890-30-00

EudraCT number

2022-000144-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Dose response

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.

Secondary objectives 5

1. • To demonstrate greater efficacy of personalized dosing by analyzing the survival rate, clinical and microbiological cure rate, length of stay and days free of supportive therapies (vasopressor agents, renal replacement therapy, extracorporeal oxygenation) vs. conventional dosage.
2. To analyze safety by evaluating the severity of haematological toxicity episodes (thrombocytopenia and anemia) and the need for transfusions of platelets and packed red blood cells.
3. To study the cost-utility of personalized dosage by analyzing the quality of life of patients through validated questionnaires.
4. To analyze the percentage of patients who reach the target pharmacokinetic and pharmacodynamic parameters for concentration, AUC0-24h/MIC ratio and %T>MIC.
5. To validate pharmacogenetic biomarkers that may be associated with drug exposure, efficacy, safety and response to treatment.

Conditions and MedDRA coding

Sepsis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients (18 years and older) receiving linezolid.
2. Diagnosis of sepsis (SOFA scale ≥ 2 points or in the case of chronic organ dysfunction, increase of 2 points compared to the baseline score).
3. Patients have started antibiotic treatment with linezolid according to usual clinical practice.

Exclusion criteria 4

1. Interruption of treatment before the first blood sample.
2. Pregnant or nursing women.
3. Known allergy or hypersensitivity to linezolid.
4. Patients will be excluded if they are already in any other intervention trials.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

1. 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.
2. Mortality: mortality from all causes will be evaluated at 14 and 28 days.
3. Changes in the SOFA scale: evolution of the daily values ​​in the SOFA scale.
4. Duration of admission to the critical care unit: number of days from admission to the critical care unit until being discharged from the unit.
5. Days free from treatment with vasopressor agents: number of days that the patient avoided receiving vasopressor agents.
6. Days free from mechanical ventilation: number of days that the patient avoided mechanical ventilation.
7. Renal Replacement Therapy Free Days: Number of days the patient avoided renal replacement therapy.
8. Days free of extracorporeal therapy: number of days that the patient avoided the use of extracorporeal membrane oxygenation.
9. Percentage of patients in therapeutic range: the percentage of patients in therapeutic range will be evaluated, 2-7 mg/L
10. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Sponsor organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Address

Travesia Da Choupana S/n

City

Santiago De Compostela

Postcode

15706

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Anxo Fernández Ferreiro

Public contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Contact name

Anxo Fernández Ferreiro

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications