Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
45
Countries
1
Sites
5
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.
To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock.
Key facts
- Sponsor
- Friedrich-Schiller-Universitaet Jena, Friedrich-Schiller-Universitaet Jena
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 30 Jun 2022 → 21 May 2025
- Decision date (initial)
- 2024-10-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bundesministerium für Bildung und Forschung (BMBF)
External identifiers
- EU CT number
- 2024-515776-12-00
- EudraCT number
- 2021-002300-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock.
Conditions and MedDRA coding
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.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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.
Exclusion criteria 16
- Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4,000/µL; Neutrophil/Thrombocyte 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 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.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Safety as assessed by myelotoxicity until day 14 is the primary endpoint.
Secondary endpoints 5
- Degree of organ dysfunction measured by SOFA score.
- Occurrence of Adverse Events.
- Occurrence of Cardiotoxicity.
- Survival at day 14, 28 and 90.
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Epirubicin 50 mg HEXAL® Injektionslösung, 2 mg/ml
PRD823269 · Product
- Active substance
- Epirubicin Hydrochloride
- Substance synonyms
- 4´-EPIDOXORUBICIN HYDROCHLORIDE, PIDORUBICIN HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15 mg/m2 milligram(s)/sq. meter
- Max total dose
- 15 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB03 — EPIRUBICIN
- Marketing authorisation
- 50400.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- study specific labelling
Placebo 1
Isotonische Kochsalzlösung Fresenius
PRD2128227 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 ml millilitre(s)
- Max total dose
- 50 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 6096595.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- study specific labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Friedrich-Schiller-Universitaet Jena
- Sponsor organisation
- Friedrich-Schiller-Universitaet Jena
- Address
- Am Klinikum 1, Lobeda Lobeda
- City
- Jena
- Postcode
- 07747
- Country
- Germany
Scientific contact point
- Organisation
- Friedrich-Schiller-Universitaet Jena
- Contact name
- Prof. Sebastian Weis
Public contact point
- Organisation
- Friedrich-Schiller-Universitaet Jena
- Contact name
- Prof. Sebastian Weis
Friedrich-Schiller-Universitaet Jena
- Sponsor organisation
- Friedrich-Schiller-Universitaet Jena
- Address
- Am Klinikum 1, Lobeda Lobeda
- City
- Jena
- Postcode
- 07747
- Country
- Germany
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 45 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Jena KöR
Klinik für Anästhesiologie und Intensivmedizin, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin Greifswald KöR
Klinik für Anästhesie, Intensiv-, Notfall- und Schmerzmedizin, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaetsklinikum Wuerzburg AöR
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, In Der Schornau 23-25, Langendreer, Bochum
Medizinische Hochschule Hannover
Klinik für Nieren- und Hochdruckerkrankungen, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-06-30 | 2025-05-21 | 2022-10-19 | 2025-03-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515776-12_p | 07 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient_2024-515776-12_p | 05 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF representative_2024-515776-12_p | 05 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_declarationofconsilarity_2024-515776-12 | 01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_formerlynotcapableofgivingIC_2024-515776-12_p | 05 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informationforfamilymembers_2024-515776-12 | 01 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Epirubicin_2024-515776-12 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-19 | Germany | Acceptable 2024-09-26
|
2024-10-01 |