Epirubicin for the Treatment of Sepsis & Septic Shock

Phase 2

Completed

Conditions: Patients with sepsis or septic shock, currently hospitalized at the Intensive Care Unit (ICU) or Intermediate Care (IMC) regardless where the sepsis was first diagnosed.

Registration Number: 2024-515776-12-00

Lead Sponsor: Friedrich-Schiller-Universitaet Jena, Friedrich-Schiller-Universitaet Jena

Brief Summary: To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ended

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Written informed consent of subject or its authorized representative or legal representative or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent.

Patients >18 years with sepsis or septic shock, currently hospitalized at the ICU or IMC regardless where the sepsis was first diagnosed

Sepsis diagnosis, as currently defined, within 48 hours prior to screening regardless of site of infection.

Exclusion Criteria

Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4,000/µL; Neutrophil/Thrombocyte Count below Lower Limit of Normal)

Acute liver failure following the European Association for the Study of the Liver definition as International Normalized Ratio (INR) >1.5 and elevation of transaminases >= 3 times of the upper normal limit (European Association for the Study of the Liver. Electronic address et al., 2017).

Pregnancy during all trimester/breast-feeding.

Chronic mechanical ventilation dependency.

Cystic fibrosis.

Concomitant medication with Verapamil or Cimetidine.

Prior enrollment in this study.

Participation in another clinical intervention trial.

Weight >135 kg/BMI >45.

Ongoing or History of chemotherapy.

Hypersensitivity to epirubicin.

History of bone marrow or solid organ transplantation.

Immunosuppressive therapy.

Acute severe infection within 4 weeks prior to admission (Hospitalization for an infection or in case of hospital acquired infection transfer to a higher level of care due to the infection)

Chronic infection.

Cardiomyopathy with a documented ejection fraction <30% or ICD implantation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety as assessed by myelotoxicity until day 14 is the primary endpoint.		Safety as assessed by myelotoxicity until day 14 is the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Cardiotoxicity.		Occurrence of Cardiotoxicity.
Survival at day 14, 28 and 90.		Survival at day 14, 28 and 90.
Degree of organ dysfunction measured by SOFA score.		Degree of organ dysfunction measured by SOFA score.
Occurrence of Adverse Events.		Occurrence of Adverse Events.
SOFA “Success” rate defined as a decrease of procalcitonin (PCT) serum concentration by 80% or more of its intra-individual peak value or to 0.5 μg/L or lower within 72 hours after randomization.		SOFA “Success” rate defined as a decrease of procalcitonin (PCT) serum concentration by 80% or more of its intra-individual peak value or to 0.5 μg/L or lower within 72 hours after randomization.

Trial Locations

Locations (5): Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
🇩🇪
Bochum, Germany
Universitaetsklinikum Wuerzburg AöR
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Wuerzburg, Germany
Universitaetsmedizin Greifswald KöR
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Greifswald, Germany
Universitaetsklinikum Jena KöR
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Jena, Germany
Medizinische Hochschule Hannover
🇩🇪
Hanover, Germany
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
🇩🇪Bochum, Germany
Tim Rahmel
Site contact
+4923429980025
Tim.Rahmel@ruhr-uni-bochum.de