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Epirubicin for the Treatment of Sepsis & Septic Shock
EU CTIS ID: 2024-515776-12-00
What this study is testing
To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock.
- Therapeutic exploratory (Phase II)
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
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
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.