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Epirubicin for the Treatment of Sepsis & Septic Shock

NCT05033808 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Epirubicin

Epirubicin is given once over 15 Minutes via a central line

DRUG

Placebo

NaCl is given once over 15 Minutes via a central line

Sponsors & Collaborators

  • Ruhr University of Bochum

    collaborator OTHER

  • University Medicine Greifswald

    collaborator OTHER

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Sebastian Weis, M.D. · Jena University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033808 on ClinicalTrials.gov