Evaluation of safety of low dose epirubicin in patients with Sepsis and septic shock.

Phase 1

Active, not recruiting

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.
MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2021-002300-12-DE

Lead Sponsor: Friedrich Schiller University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 45

Inclusion Criteria

Patients (= 18 years) with sepsis or septic shock, currently hospitalized at the ICU or IMC regardless where the sepsis was first diagnosed.
Sepsis diagnosis within 48 hours prior to screening.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

•Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4000/?L; Neutrophil/ platelets Count below Lower Limit of Normal).
•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 or admission to higher level clinical care facility for infection).
•Chronic infection.
•Cardiomyopathy with a documented ejection fraction <30% or ICD implantation.
•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 (2).
•Pregnancy during all trimesters/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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock;Secondary Objective: To assess efficacy of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock;Primary end point(s): Safety as assessed by myelotoxicity until day 14.;Timepoint(s) of evaluation of this end point: continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12 and day 14.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Degree of organ dysfunction measured by SOFA Score.<br>Occurrence of Adverse events.<br>Occurrence of Cardiotoxicity.<br>Survival at day 14, 28 and 90.<br>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;Timepoint(s) of evaluation of this end point: continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12, day 14, day 28 and day 90.