Epirubicin for the Treatment of Sepsis & Septic Shock

Who is this study for? Patients with Sepsis
What treatments are being studied? Epirubicin
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The study will assess the safety of low doses of epirubicin in sepsis patients. Therefore the study will look for side effects in patients treated with low dose epirubicin compared to control patients. In animals, low dose epirubicin has been shown to induce tolerance to infection and increase survival in septic mice. The study will also look for positive effects on organ function in humans. The investigators hypothesize that low-dose epirubicin can be used therapeutically to improve the disease course and lessen mortality of patients with sepsis. In a first step, the investigators aim at proving that low-dose epirubicin can safely be administered to sepsis patients and will perform a dose-escalation multi-center trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• admitted to the ICU with sepsis or septic shock, diagnosed within the previous 24 hours

Locations
Other Locations
Germany
University Hospital Knappschafstkrankenhaus Bochum
NOT_YET_RECRUITING
Bochum
University Medicine Greifswald
NOT_YET_RECRUITING
Greifswald
Universitätsklinikum Hamburg Eppendorf
NOT_YET_RECRUITING
Hamburg
Jena University Hospital
RECRUITING
Jena
Universitätsklinikum Würzburg
NOT_YET_RECRUITING
Würzburg
Contact Information
Primary
Sebastian Weis, M.D.
Sebastian.Weis@med.uni-jena.de
+49 (0) 3641-932
Backup
Daniel O Thomas-Rüddel, M.D.
Daniel.Thomas@med.uni-jena.de
+49 (0) 3641-932
Time Frame
Start Date: 2022-10-19
Estimated Completion Date: 2024-12
Participants
Target number of participants: 45
Treatments
Placebo_comparator: Placebo
Administration of NaCl i.v. as placebo once.
Experimental: Epirubicin Phase I
Administration of epirubicin i.v. 3.75 mg/m2 once.
Experimental: Epirubicin Phase II
Administration of epirubicin i.v. 7.5 mg/m2 once.
Experimental: Epirubicin Phase III
Administration of epirubicin i.v. 15 mg/m2 once.
Related Therapeutic Areas
Sponsors
Collaborators: University Medicine Greifswald, Ruhr University of Bochum
Leads: Jena University Hospital

This content was sourced from clinicaltrials.gov