Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2022-10-19
2024-12-31
Brief Summary
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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.
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Detailed Description
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Epirubicin is a chemotherapeutic substance used to treat cancer. In animal experiments, it has been shown that doses much lower than the ones used in oncology, can induce tolerance in infected animals. Animals treated with epirubicin survive an infectious dose that kills animals not treated with epirubicin. Before this approach can be studied in a large group of sepsis patients, it is necessary that epirubicin in low doses can be safely used in this population.
Therefore in this study, septic patients will be treated with low doses of epirubicin and systematically assessed for serious side effects. Some patients will be treated with placebo for comparison. The trial will be conducted as a dose escalation study with three groups. This means that the first group of patients will receive only a quarter of the dose shown to be effective in animal experiments. Only if no serious side effects are observed will the dose be increased in the second group and again in the third group.
In addition, the study will look for signs of beneficial effects on organ function in human patients with sepsis, pharmacokinetics of epirubicin in sepsis patients and changes in the inflammatory response.
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 phase IIa dose-escalation multi-center trial.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Administration of NaCl i.v. as placebo once.
Placebo
NaCl is given once over 15 Minutes via a central line
Epirubicin Phase I
Administration of epirubicin i.v. 3.75 mg/m2 once.
Epirubicin
Epirubicin is given once over 15 Minutes via a central line
Epirubicin Phase II
Administration of epirubicin i.v. 7.5 mg/m2 once.
Epirubicin
Epirubicin is given once over 15 Minutes via a central line
Epirubicin Phase III
Administration of epirubicin i.v. 15 mg/m2 once.
Epirubicin
Epirubicin is given once over 15 Minutes via a central line
Interventions
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Epirubicin
Epirubicin is given once over 15 Minutes via a central line
Placebo
NaCl is given once over 15 Minutes via a central line
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Weight \>135 kg/BMI \>45.
* Active neoplasia.
* 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 AICD (automatic internal cardioverter defibrillator) 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.
18 Years
ALL
No
Sponsors
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Ruhr University of Bochum
OTHER
University Medicine Greifswald
OTHER
Jena University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sebastian Weis, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jena University Hospital
Locations
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Jena University Hospital
Jena, Thuringia, Germany
University Hospital Knappschafstkrankenhaus Bochum
Bochum, , Germany
University Medicine Greifswald
Greifswald, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Figueiredo N, Chora A, Raquel H, Pejanovic N, Pereira P, Hartleben B, Neves-Costa A, Moita C, Pedroso D, Pinto A, Marques S, Faridi H, Costa P, Gozzelino R, Zhao JL, Soares MP, Gama-Carvalho M, Martinez J, Zhang Q, Doring G, Grompe M, Simas JP, Huber TB, Baltimore D, Gupta V, Green DR, Ferreira JA, Moita LF. Anthracyclines induce DNA damage response-mediated protection against severe sepsis. Immunity. 2013 Nov 14;39(5):874-84. doi: 10.1016/j.immuni.2013.08.039. Epub 2013 Oct 31.
Thomas-Ruddel D, Bauer M, Moita LF, Helbig C, Schlattmann P, Ehler J, Rahmel T, Meybohm P, Grundling M, Schenk H, Kocher T, Brunkhorst FM, Graler M, Heger AJ, Weis S; EPOS-1 study group; SepNetCriticalCare TrialsGroup. Epirubicin for the Treatment of Sepsis and Septic Shock (EPOS-1): study protocol for a randomised, placebo-controlled phase IIa dose-escalation trial. BMJ Open. 2024 Apr 22;14(4):e075158. doi: 10.1136/bmjopen-2023-075158.
Other Identifiers
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2021-002300-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
01EN2001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DRKS00025884
Identifier Type: REGISTRY
Identifier Source: secondary_id
EPOS_ZKSJ0134
Identifier Type: -
Identifier Source: org_study_id
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